Bulletin Officiel n°2000-33

Liste du 30 juin 2000 relative aux enregistrements par l'Agence française de sécurité sanitaire des produits de santé (direction de l'évaluation des dispositifs médicaux), au cours du deuxième trimestre 2000, des réactifs destinés aux analyses de biologie médicale dans le cadre du décret du 19 avril 1996

SP 4 48
2365

NOR : MESP0030366K


(Texte non paru au Journal officiel)

(Voir tableau pages suivantes.)

REQUÊTE 2000

N° AFSSAPSNOM COMMERCIALDISTRIBUTEURRÉFÉRENCE
u 89342aeroset albumine bcp* ref 7d54-01abbott diagnostic
t 85432contrôles architect anti-hbc* ref 7c17-10abbott diagnostic
t 86692cell-dyn immuno plt (cd61)* ref 03h05-01abbott diagnostic
t 82282kit de reactifs architect b12* ref 6c09-25/-20abbott diagnostic
u 89432aeroset phosphatase alcaline* ref 7d55-01abbott diagnostic
t 82292calibrateurs architect b12* ref 6c09-01abbott diagnostic
t 84282coffet-reactifs axsym hav ab m2.0* ref 6c69-20abbott diagnostic
t 84292controles axsym hav ab m2.0* ref 6c69-10abbott diagnostic
u 89332aeroset asparate aminotransferase* ref 7d81-01abbott diagnostic
u 89992aeroset calcium* ref 7d61-01abbott diagnostic
t 84562kit de reactifs architect psa total* ref 6c06-25/30abbott diagnostic
u 89952aeroset hdl direct* ref 7d67-01abbott diagnostic
t 84572calibrateurs architect psa total* ref 6c06-01abbott diagnostic
u 89962aeroset magnesium* ref 7d07-01abbott diagnostic
u 89972aeroset gamma glutamyl transferase* ref 7d65-01abbott diagnostic
t 85422calibrateur 1 architect anti-hbc* ref 7c17-01abbott diagnostic
t 84582controles architect psa total* ref 6c06-10abbott diagnostic
t 87442murex hbs ag version 3* ref ge34/36abbott diagnostic
u 90682aeroset phosphore* ref 7d71-01abbott diagnostic
u 91132aeroset proteines totales* ref 7d73-01abbott diagnostic
t 85412kit de reactifs architect anti-hbc* ref 7c17-20/-25/30/-35abbott diagnostic
u 89792calibrateur proteines urine/lcr* 1e71-01abbott diagnostic
u 91142aeroset glucose* ref 7d66-01abbott diagnostic
u 89982aeroset lactate deshydrogenase* ref 7d69-01abbott diagnostic
u 90162aeroset amylase* ref 7d58-01abbott diagnostic
u 89422aeroset bilirubine totale* ref 7d60-01abbott diagnostic
u 89322aeroset albumine bcg* ref 7d53-01abbott diagnostic
u 90832abx diagnostics aso standard* ref a11a00162abx-hematologie
u 92332abx diagnostics serumproteins standard* ref a11a00327abx-hematologie
u 90812abx diagnostics rf standard* ref a11a00160abx-hematologie
u 92242abx diagnostics lipoprotein (a) control i/ii* ref a11a00185abx-hematologie
u 92252abx diagnostics accelerator iv* ref a11a00419abx-hematologie
u 92322abx diagnostics apolipoproteins standard* ref a11a00178abx-hematologie
u 92372abx diagnostics serumproteins control i/ii* ref a11a00328abx-hematologie
u 92302abx diagnostics lipoprotein (a) standard* ref a11a00184abx-hematologie
u 91662abx diagnostics crp 400* ref a11a00153abx-hematologie
u 92272abx diagnostics apolipoproteins control* ref a11a00180abx-hematologie
u 91652abx diagnostics crp standard* ref a11a00156abx-hematologie30500
u 92122abx diagnostics accelerator ii* ref a11a00417abx-hematologie50500
u 92132abx diagnostics accelerator i* ref a11a00416abx-hematologie240500
u 92152abx diagnostics accelerator iii* ref a11a00418abx-hematologie240500
u 90892abx diagnostics ige standard* ref a11a00170abx-hematologie30500
u 90902abx diagnostics beta 2 microglobulin standard* ref a11a00173abx-hematologie30500
u 92182abx diagnostics sample diluent* ref a11a00331abx-hematologie240500
u 90912abx diagnostics beta 2 microglobulin control* ref a11a00174abx-hematologie30500
u 92222abx diagnostics alpha-1-anti-trypsine* ref a11a00140abx-hematologie240500
u 90492ebv check igg* ref 5429all.diag200600
u 88782simplify d-dimer* ref 5428all.diag130600
t 75832tampon de lavage ige specifiques* ref 472843bayer diagnostics120500
u 90632calibrateur q* ref 118220bayer diagnostics140600
u 90622reactifs psa/acs 180 et advia centaur* ref 118152/118154-118156/118157bayer diagnostics140600
t 74792reactif lite ige specifiques* ref 472855bayer diagnostics120500
u 90982diluant thcg acs 180/advia centaur* ref 115249/117143bayer diagnostics290600
t 88492facteur rhumatoides/synchronl x* ref 475136beckman coulter france290500
u 92552trousse calibrateurs microalbumine (ma) synchron cx* ref 475057beckman coulter france60600
u 92082reactif tampon 4 (buf4)* ref 447420beckman coulter france90600
u 92472trousse calibrateurs prealbumine (pab)* ref 475033beckman coulter france60600
u 92482calibrateur prealbumine (pab)* ref 475081beckman coulter france220600
u 92732reactif alcool (etoh) synchron* ref 474947beckman coulter france290600
u 92582act5 diff rinse* 8547167beckman coulter france220600
u 92542calibrateur microalbumine (ma) synchron lx* ref 475089beckman coulter france60600
u 92532reactif microalbumine (ma) synchron* ref 475100beckman coulter france280600
u 92742calibrateurs alcool (etoh) synchron* ref 474994beckman coulter france90600
u 92092reactif digoxine (dig)* ref 447410beckman coulter france90600
t 84832tritest cd3 fitc/cd16+cd56 pe/cd45 percp* ref 340300 ; 340403becton dickinson biosciences europe130400
u 90312bbl sensi-disc meropenem 10æg-mem 10* ref 4332048becton dickinson biosciences europe200400
u 90302bbl sensi-disc loracarbef 10æg-lor 10* ref 232139becton dickinson biosciences europe200400
t 86852bbl sensi-disc isepamycin 30æg* ref 232141becton dickinson biosciences europe200400
u 92062bactec mgit 960 supplement kit* ref 245124becton dickinson biosciences europe220500
t 78432euroblot profil sle* ref da 1590/-1003-3g/-1005-3/-1001-3gbio advance50500
s 65892fia estomac-facteur intrinseque* ref fa1362-1005-1/2005-1/1010-1.fa1360-1005/2005/10bio advance20500
t 87182lyphochek urine bone markers control level 1&2* ref 406bio-rad sa200600
t 86502rpr 100/rpr 500* ref 72505/72506bio-rad sa100400
t 86492tpha 100/200/screening 500/screening 1000* ref 500/501/502/503bio-rad sa100400
u 89632syphilis igg microplate eia* ref 32525/32526bio-rad sa200500
u 91642tpha oc 2000* 72507bio-rad sa100400
t 87192liquichek urine toxicology control level s1 low opiate* ref 466bio-rad sa200600
u 90442genscreen plus hiv ag-ab* ref 72375/72376bio-rad sa130400
t 88072scangel abo/rh1/rh1 clones : 15750f7-x9-ab563a5a2-b9a4-t3d2f6-ms26* ref 86443/4bio-rad sa200400
u 89622syphilis igm microplate eia* ref 32527bio-rad sa220500
t 87202liquichek urine toxicology control level s2 low opiate* ref 467bio-rad sa200600
t 86562triage cardiac calibration verification controls* ref 97002biomedical diagnostics sa220500
u 90452virorol syphilis total* ref bbs900biomedical diagnostics sa20500
t 86542triage cardiac panel* ref 97000biomedical daignostics sa220500
t 86552triage cardiac control set* ref 97001biomedical diagnostics sa220500
u 91812ca arz* ref 61046biomerieux50500
u 91822glucose hexokinase* ref 61047biomerieux50500
t 87452bioclot apc sensitivity* ref 50510biopool international140400
u 89492access hybritech sap sample diluent* ref 37206biorad300500
u 89532access hybritech free saps calibrators* ref 37215biorad300500
u 89472access hybritech psa calibrators* ref 37205biorad300500
u 89542access hybritech free psa qc* ref 37219biorad300500
u 89522access hybritech free psa* ref 37210biorad300500
u 89482access hybritech psa qc* ref 37209biorad300500
u 89462access hybritech psa* ref 37200biorad300500
u 89642cmv ta microplate eia* ref 32539/32540 = L92441biorad300500
t 88452biotest anti-ebv (vca) igm elisa* ref 807018biotest sarl220500
t 88462biotest anti-ebv (vca) igg elisa* ref 807019biotest sarl20500
u 90132controle anti-hbc magia* ref 118663biotrol diagnostic90500
u 89382microalbumine* ref b01717biotrol diagnostic110400
u 90122anti-hbc magia* ref 118662biotrol diagnostic90500
t 88442pcs-afp* ref 70321bipharco200400
t 84132pcx-ige* ref 70501bipharco220600
t 88422pcx-tt3* ref 70211 bipharco200400
t 88432pcx-tt4* ref 70201bipharco200400
t 88592brahms pctq* ref 106025brahms france290500
t 88622lumitest trak humain* ref 107.1brahms france60600
t 84342syva rapid cup 3 thc/coc/opi* ref 6a709 dade behring sa
280600
u 92442emit ii plus dosage de methadone* ref 9e029dade behring sa200600
u 89682cartouche reactifs flex immunoglobuline a* ref df74dade behring sa290500
u 89672cartouche reactifs flex immunoglobuline m* ref df81dade behring sa290500
u 89662cartouche reactifs flex immunoglobuline g* ref df76dade behring sa290500
u 89692etalon proteines specifiques* ref dc51dade behring sa140400
u 89922bb news* ref 3532679226148dectra pharm100400
m 22792ptu-ab* ref 79054diagast laboratoires100400
u 90542phenoplac 16 rh-kell* ref 79715diagast laboratoires170500
u 88732safety test abo* ref 79059diagast laboratoires250400
u 91742proteinase 3-anca (pr-3 anca)* ref pr3.102diasorin sa250500
u 91862anca screening (pr3-et mpo-anca)* ref cp101diasorin sa250500
u 90392tampon de lavage* ref m2600999941diasorin sa170500
t 87232eti-mp-igm* ref 4700diasorin sa120500
u 91732anti-gbm antibodies* ref gp 104xdiasorin sa250500
u 91562myeloperoxydase-anca (mpo-anca)* ref mpo 103diasorin sa250500
u 91572ebv-vca-igm elisa* ref akm 0510dsdiasorin sa120500
u 90272eti-jo-1 (systeme eti-ana profiles)* ref 104901diasorin sa220500
u 91872anti-gbm anca screening* ref gcp 100diasorin sa250500
u 92802immulite 2000 toxoplasmose igm* ref l2ktm2/l2ktm6dpc france240500
u 92792immulite 2000 toxoplasmose igg quantitatif* l2ktxq2/l2ktxq6dpc france240500
t 84452dynal classic-ssp hla b27* ref dyn 55801dynal france sa100400
u 90262microtech anti-k (keli) clone ms56/igm* ref 141449-141479efs bretagne est110400
u 90232microtech anti-d (rh1) clone p3187/igm* ref 141-144/474efs bretagne est110400
t 88632leptospira igm serion elisa classic* ref esr125melitech, division de seppim sa170500
u 91002aia pack troponine i solution de dilution des echantillons* ref e06-01-5598eurogenetics france240500
u 91042aia pack myoglobine solution de dilution des echantillons* ref e06-01-5597eurogenetics france240500
u 92772cyclerplate system protrans dr b dqb1* ref 200050france biochem280600
u 90082kit titan hb-alc* ref 0185helena france sa220500
u 88902hdl-c immuno fs* ref 135219910021/704/717immunochimie internationale250400
t 88352ferritine fs* ref 170599910016/170599910730immunochimie internationale170500
u 90602il test cal2(bg+electrolytes)* ref 98342-00instrumentation laboratory20500
u 93042il test calibration standard 140 mmol/l na+, 5mmol/lk* ref 35140-00instrumentation laboratory280600
u 91942il test co-oxymeter cleaning agent* ref 09833900instrumentation laboratory220500
u 90612il test tca-ps* ref 0020006300instrumentation laboratory250400
t 87652anca fluorescence fixation a l'ethanol* ref 10060-11/10300-11international genetic technologies50500
t 87642anca fluorescence fixation au formol* ref 10060-12/10300-12international genetic technologies50500
s 63472flowpra i* ref fl1-30international genetic technologies140400
s 63482flowpra ii* ref fl2-30international genetic technologies140400
s 63492flowpra i et ii* ref fl12-60international genetic technologies140400
t 88252sugar chex, niveau eleve* ref 220306/220318international genetic technologies180400
t 88262sugar chex, niveaux* ref 220403/220412/220418international genetic technologies180500
t 88232sugar chex, niveau faible* ref 220106/22118international genetic technologies180500
t 88242sugar chex, niveau moyen* ref 220206/220218international genetic technologies250400
t 87632urichrom ii* ref 22221international microbio180500
u 91802hdl/ldl calibrateurs* ref 981657konelab140400
u 92662hdl-cholesterole* ref 981655konelab100500
u 91792albumine/microalbumine* ref 981660konelab220600
t 88312solution colorante safranine 0 a 1 %* ref cl620241labo-moderne100400
t 87222quikread crp* ref 5110.0laboratoires fumouze130400
t 87702idea stfr it controle eleve* ref 5068.0laboratoires fumouze130400
t 87712idea stfr it controle bas* ref 5066.5laboratoires fumouze130400
u 90422diarlex mb* ref 5328.1laboratoires fumouze30500
u 89912albumine urinaire contrôle haut* ref ma1412laboratoires randox90600
j 07750magnesium* ref mg 573/570laboratoires randox110400
t 86732amoxicilline/acide clavulanique 30æg* ref aug30cmast diagnostic110500
t 86482mecillinam 10æg* ref mec10cmast diagnostic110500
t 86082acide pipemidique 20æg* pip20cmast diagnostic110500
t 86102acide nalidixique 30æg* ref na30cmast diagnostic110500
t 86112amoxicilline 25æg* ref a25cmast diagnostic110500
t 86122ampicilline 10æg* ref ap10cmast diagnostic110500
t 86452cefalotine 30æg ref kf30cmast diagnostic110500
t 86712imipeneme 10æg* ref imi10cmast diagnostic110500
t 86072amikacine 30æg* ref ak30cmast diagnostic110500
t 86472cotrimoxazole 25æg* ref ts25cmast diagnostic110500
t 86442gentamicine 500æg* ref gm500cmast diagnostic110500
t 86722tazobactam/piperacilline 85æg* ref ptz85cmast diagnostic110500
t 86742tobramycine 10oeg* ref tn10cmast diagnostic110500
t 86752chloramphenicol 30æg* ref c30cmast diagnostic110500
t 86992spectinomycine 100æg* ref spc 100cmast diagnostic110500
t 87002ticarcilline 75æg* ref tc75cmast diagnostic110500
t 87012rifampicine 30æg* ref rp30cmast diagnostic110500
t 87022tetracycline 30æg* ref t30cmast diagnostic110500
t 86462ciprofloxacine 5æg* ref cip5cmast diagnostic110500
u 91102menotimematara sarl90600
u 91592glucose control n* ref 24061menarini diagnostics120500
u 91602glucose control h* ref 24166menarini diagnostics120500
t 88332controles pour nichols advantage epo* ref 64-7412nichols institute diagnostics20500
t 82522ahg polyspecific (anti-igg polycl/-c3b ;-c3d mc) enhanced/bioclone* ref 959050/52ortho clinical diagnostics france200400
u 90402vitros chemistry products tibc kit* ref 8867541ortho clinical diagnostics france210400
u 90642vitros chemistry li dt slides* ref 8622011ortho clinical diagnostics france170500
t 87402serum crosslaps one step elisa* ref 4crl4000osteometer s/a200400
t 84672lactate pro tm* ref 55-330500 test strips ; 55-330501 meteroxford instruments30500
u 92632dryspot legionella latex test/legionella pneumophila serogroupe 1* ref dr200moxoid280600
u 92652drysport legionella latext test/autres espèces de legionella* ref dr200moxoid280600
u 92642dryspot legionella latex test/legionella pneumophila serogroupe 2 14* ref dr210moxoid220600
u 90332gelose pour clostridium difficile* ref pb5054aoxoid220600
u 91992obis salmonella* ref id580moxoid220600
u 89392gelose bcye sans l-cysteine pour legionella* ref p05028aoxoid220600
u 91672o.b.i.s. pyr* ref id580moxoid220600
u 90432test au latex pour detection des proteines liant penicilline (plp2')* ref fdr900moxoid110400
t 86062serum de veau foetal* ref ch30160-01/-02perbio science france140400
u 91252gx2 pollen de graminees* ref 14-4192-01pharmacia & upjohn100500
u 91152f233 ovomucoide* ref 14-4805-01pharmacia & upjohn100500
u 91162tx2 pollen d'arbres* ref 14-4270-01pharmacia & upjohn100500
u 9117212 dolichovespula maculata* ref 14-4221-01pharmacia & upjohn100500
u 91182tx4 pollen d'arbres* ref 14-4200-01pharmacia & upjohn100500
u 91232172 cladotanytarsus lewisi* ref 14-4361-01pharmacia & upjohn100500
u 91202tx6 pollen d'arbres* ref 14-4202-01pharmacia & upjohn100500
u 9122215 dolichovespula arenaria* ref 14-4223-01pharmacia & upjohn100500
u 91192g71 phalaris arundinacea* ref 14-4360-01pharmacia & upjohn100500
u 91262gx1 pollen de graminees* ref 14-4163-01pharmacia & upjohn100500
u 91332g70 elymus triticoides* ref 14-4344-01pharmacia & upjohn100500
u 91492w19 parietaria officinalis* ref 14-4186-01pharmacia & upjohn100500
u 91212tx3 pollen d'arbres* ref 14-4271-01pharmacia & upjohn100500
u 91272ex71 plumes* ref 14-4277-01pharmacia & upjohn100500
u 91412t20 prosopis juliflora* ref 14-4234-01pharmacia & upjohn100500
u 91392mx2 moisissures* ref 14-4320-01pharmacia & upjohn100500
u 91422c74 gelatine* ref 14-4854-01pharmacia & upjohn100500
u 91382tx7 pollen d'arbres* ref 14-4272-01pharmacia & upjohn100500
u 91402gx4 pollen de graminees* ref 14-4194-01pharmacia & upjohn100500
u 91502tx9 pollen d'arbres* ref 14-4274-01pharmacia & upjohn100500
u 91512t22 carya pecan* ref 14-4236-01pharmacia & upjohn100500
u 91342g17 paspalum notatum* ref 14-4189-01pharmacia & upjohn100500
u 91282ex70 rongeurs* ref 14-4276-01pharmacia & upjohn100500
u 91242tx5 pollen d'arbres ref 14-4201-01pharmacia & upjohn100500
u 91302t72 arecastrum romanzoffianum* ref 14-4373-01pharmacia & upjohn100500
u 91292t21 melaleuca leucadendron* ref 14-4235-01pharmacia & upjohn100500
u 91352f280 piper nigrum* ref 14-4817-01pharmacia & upjohn100500
u 91312t73 casuarina equisetifolia* ref 14-4374-01pharmacia & upjohn100500
u 91322tx1 pollen d'arbres* ref 14-4199-01pharmacia & upjohn100500
u 91362f214 spinachia oleracea* ref 14-4432-01pharmacia & upjohn100500
u 91372fx73 viandes* ref 14-4825-01pharmacia & upjohn100500
t 83472drugwipe amphetamines* ref 3137/04pretory sa20500
u 91112lugol* ref 36730-2/36730-3/36730-4reactifs ral100400
s 69672amplicor hbv monitor test* ref 07 57152roche diagnostics130400
t 83502amplicor hcv amplification kit. v2.0* ref 1111094roche diagnostics30500
t 83512cobas amplicor hcv detection kit. v2.0* ref 1111132roche diagnostics30500
u 91062elecsys cortisol calset* ref 1875124roche diagnostics220600
t 83522amplicor hcv controls kit v2.0* ref 1111175roche diagnostics30500
u 91952stfr control set* ref 2148340roche diagnostics220500
t 91962elecsys nse* ref 2133113roche diagnostics140600
u 91072elecsys ca 72-4 calset* ref 1776274roche diagnostics140600
u 91052preciset rf* ref 2172828roche diagnostics140600
t 83492amplicor hcv specimen preparation kit v2.0* ref 1111086roche diagnostics30500
u 90762elecsys cortisol* ref 1875116roche diagnostics90600
u 92012lp(a) control set* ref 1660993roche diagnostics220500
u 91972elecsys nse calset* ref 2133121roche diagnostics140600
u 93052preciset stfr* ref 2148331roche diagnostics290600
t 86532cobas integra amikacin* ref 0767166roche diagnostics250400
u 90772elecsys ca 72-4* ref 1776258roche diagnostics170500
u 90462elecsys tg calset* ref 1820940roche diagnostics250400
u 90462elecsys thyroglobuline* ref 1820834roche diagnostics250400
u 92752anti-kappa/lambda-per* ref 4745sebia sa280600
u 89732hydragel 7 isoformes ck* ref 4561sebia sa20500
t 84732strep a sign* ref v8500servibio220500
t 88222kit bindazyme dosage ac anti-transglutaminase iga en technique elisa* ref mk038the binding site130600
t 88042coffret dosage du facteur rhamatoide/minineph* ref zk151.rthe binding site160600
 Réactifs contenant des radio-éléments artificiels
i. attestation provisoire		  
t 88612dynotest trak humain* ref 101.1/101.5brahms france20500
u 89452vasopressine* ref 40-6035nichols institute diagnostics290500
u 90362pharmacia ha test* ref 10-9294-01pharmacia & upjohn100400
 ii. attestation quinquennale  
p 46262active testosterone libre* ref dsl 4900brahms france60600
 Transfert d'enregistrement  
m 11482nycocard d-dimer* ref 1005510/1006427progen biotechnique sarl160600
m 11492nycocard crp serum/plasma* ref 1001641/1001634progen biotechnique sarl160600
m 11502nycocard crp sang total* ref 1001627/1001624progen biotechnique sarl160600