Bulletin Officiel n°2001-30Agence française de sécurité
sanitaire des produits de santé

Liste du 2 juillet 2001 relative aux enregistrements par l'Agence française de sécurité sanitaire des produits de santé, direction de l'évaluation des dispositifs médicaux, département diagnostic in vitro, unité évaluation, au cours du deuxième trimestre 2001, des réactifs destinés aux analyses de biologie médicale dans le cadre du décret n° 96-351 du 19 avril 1996

SP 4 48
1950

NOR : MESG0130264K


(Texte non paru au Journal officiel)
N°
AFSSAPS		NOM COMMERCIALDISTRIBUTEURDATE
d'attestation
U90072SOLUTIONS DE LAVAGE PRISM HIV O PLUS*REF 3D34-38ABBOTT DIAGNOSTIC250401
T88362LCX HIV RNA QUANTITATIF KIT EXTRACTION QIAMP (1.0ML)*REF 6E38 60ABBOTT DIAGNOSTIC70501
T88372LCX HIV RNA QUANTITATIF AMPLIFICATION DETECTION* REF 7 F53 90ABBOTT DIAGNOSTIC70501
T88382LCX HIV RNA QUANTITATIF CALIBRATEURS*REF 7 F53-70ABBOTT DIAGNOSTIC70501
T88392LCX HIV RNA QUANTITATIF CONTROLES*REF 7 F53-80ABBOTT DIAGNOSTIC70501
V97862ABX DIAGNOSTICS HBA1C CONTROL P*REF A11A00357ABX DIAGNOSTICS250401
V97872ABX DIAGNOSTICS HBA1C CONTROL N*REF A11A00356ABX DIAGNOSTICS250401
V97882ABX DIAGNOSTICS HBA1C HEMOLYSIS REAGENT*REF A11A00358ABX DIAGNOSTICS250401
V97852ABX DIAGNOSTICS HBA1C 250/500*REF A11A00402, A11A00355ABX DIAGNOSTICS260401
V97892ABX DIAGNOSTICS FRUCTOSAMINE CONTROL P*REF A11A00353ABX DIAGNOSTICS300401
V97902ABX DIAGNOSTICS FRUCTOSAMINE CONTROL N*REF A11A00352ABX DIAGNOSTICS300401
V97912ABX DIAGNOSTICS FRUCTOSAMINE CALIBRATOR*REF A11A00351ABX DIAGNOSTICS300401
V97922ABX DIAGNOSTICS FRUCTOSAMINE 300/600*REF A11A00349/350ABX DIAGNOSTICS300401
V98422CARTOUCHE DE MESURE, RP 400 (PH, P02, PC02, NAT, K+, CL-, ICA2+, GLUCOSE, HCT) *REF 118679BAYER DIAGNOSTICS60601
V98432CARTOUCHE DE RINCAGE/POUBELLE/RP400*REF 118678BAYER DIAGNOSTICS60601
V97602REACTIFS DS5-KIT HBA1C*REF 014-350BAYER DIAGNOSTICS200601
V98142REACTIF ACCUTNI (TROPONINE I)*REF 33340BECKMAN COULTER
FRANCE		70501
V98152REACTIF CALIBRATEURS ACCUTNI (TROPONINE I)*REF 33345BECKMAN COULTER
FRANCE		70501
V98162REACTIF ACCESS CONTROLES TROPONINE (ACCUTNI)*REF 33349BECKMAN COULTER
FRANCE		70501
V97522REACTIF ACCESS TESTOSTERONE*REF 33560BECKMAN COULTER
FRANCE		90501
V97532CALIBRATEURS TESTOSTERONE*REF 33565BECKMAN COULTER
FRANCE		90501
V98892ACCESS CARDIAC QC1*REF 973251BECKMAN COULTER
FRANCE		290501
V98902ACCESS CARDIAC QC2*REF 973252BECKMAN COULTER
FRANCE		290501
V98912ACCESS CARDIAC QC3*REF 973253BECKMAN COULTER
FRANCE		290501
U96442ANTI-PETIT E (RH5)/CLONES MS62+MS69/IGM*REF BA-31653/693BIOATLANTIC S.A.R.L.90501
U96452ANTI-PETIT C (RH4)/CLONE MS35/IGM*REF BA-31453/493BIOATLANTIC S.A.R.L.90501
U96462ANTI-E (RH3)/CLONES MS12+MS260/IGM*REF BA-31553/593BIOATLANTIC S.A.R.L.90501
U96472ANTI-C (RH2)/CLONES MS273/IGM*REF BA-31353/393BIOATLANTIC S.A.R.L.90501
U96482ANTI-D (RH1)/CLONES NATH28-3C11 + MS26/IGM + IGG*REF BA-31253/293BIOATLANTIC S.A.R.L.290501
V97982DOSAGE DE L'ACTIVITE WILLEBRAND*REF 901004BIOGENIC200601
U95472ELISA TRICHINOSE*REF BNBTN 96/48BIONOBIS300501
U96822COFFRET HLA B35*REF 10152224UBIONOBIS290601
U96832COFFRET HLA B5*REF 10151112UBIONOBIS290601
U96842COFFRET HLA B7*REF 10151224UBIONOBIS290601
U96852COFFRET HLA B8*REF 10151324UBIONOBIS290601
U96862COFFRET HLA B12*REF 10151424UBIONOBIS290601
U96872COFFRET HLA B14*REF 10152412UBIONOBIS290601
U96882COFFRET HLA B15*REF 10151624UBIONOBIS290601
U96892COFFRET HLA B16*REF 10151712UBIONOBIS290601
U96902COFFRET HLA B17*REF 10151812UBIONOBIS290601
U96912COFFRET HLA CW*03 *REF 10161112UBIONOBIS290601
U96922COFFRET HLA CW*04* REF 10161212UBIONOBIS290601
U96932COFFRET HLA CW*05 *REF 10161312UBIONOBIS290601
U96942COFFRET HLA CW*06 *REF 10161412UBIONOBIS290601
U96952COFFRET HLA CW*07 *REF 10161524UBIONOBIS290601
U96962COFFRET HLA CW COMPOSITE *REF 10161912UBIONOBIS290601
U96972COFFRET HLA A1 *REF 10141124UBIONOBIS290601
U96982COFFRET HLA A2 *REF 10141224UBIONOBIS290601
U96992COFFRET HLA A3 *REF 10141324UBIONOBIS290601
U97002COFFRET HLA A9 *REF 10141424UBIONOBIS290601
U97012COFFRET HLA A10 *REF 10141512UBIONOBIS290601
U97022COFFRET HLA A11 *REF 10141612UBIONOBIS290601
U97032COFFRET HLA A68 *REF 10141812UBIONOBIS290601
V97652HEPARIPEP STANDARD *REF 50301010BIOPEP S.A.110501
V97662HEPARIPEP CONTROLE BAS *REF 50401010BIOPEP S.A.110501
V97672HEPARIPEP CONTROLE HAUT *REF 50401011BIOPEP S.A.110501
V98082CHROMOPEP HEPARINE 3 *REF 50104000BIOPEP S.A.110501
V98092CHROMOPEP HEPARINE 6 *REF 50104010BIOPEP S.A.110501
V98102NORMAPOOL*REF 50300000BIOPEP S.A.110501
V99272PLASMAPEP NORMAL*REF 50401030BIOPEP S.A.140601
V99282PLASMAPEP PATHOLOGIQUE*REF 50401031BIOPEP S.A.140601
U94792EBV VCAN-1 IGG, TEST ELISA EN MICROPLAQUE *REF 72939BIO-RAD SA70501
U94782EBV EA-D IGG, TEST ELISA EN MICROPLAQUE *REF 72938BIO-RAD SA70501
U94792EBV VCA IGM, TEST ELISA EN MICROPLAQUE *REF 72936BIO-RAD SA70501
U96112EBV VCA IGG, TEST ELISA EN MICROPLAQUE*REF 72937BIO-RAD SA70501
V98072PASTOREX MENINGITIS CONTROL REAGENTS * REF 61624BIO-RAD SA180501
U96522MICROMAT II HEMOGLOBIN A1C TEST*REF 280 0008BIO-RAD SA290501
U96372BIOTEST ERYTYPE S ABO/CLONES A003-B005-BS63+BS85*REF 806115BIOTEST S.A.R.L.50401
U96542ERYTYPE ABO+D/CLO A003B005-BS83-BS85-BS226
BS232-P3X25513G8-P3X61-
P3X234*REF80610		BIOTEST S.A.R.L.50401
V97992BIOTEST ELPHA HLA-AB LOW RES*REF. 826175BIOTEST S.A.R.L.260601
U9365240/41 ADENO-STRIP
*REF 066/C-1003		CORIS BIOCONCEPT220501
V97762FLEX DEPISTAGE URINAIRE OPIACES*REF DF93ADADE BEHRING S.A.180501
U97182PHENOSCREEN ANTI-PETIT E(RH5)/CLONE 2671G639-11/IGM*REF 73613DIAGAST
LABORATOIRES		30501
V97782B-SCREEN*REF 80226DIAGAST
LABORATOIRES		260601
V98242ANCA(MPO/PR. 3) DOT *REF ANCAD-20DIASORIN S.A220501
U95832DYNAL CLASSIC-SSP HLA B13*REF DYN 586.02DYNAL FRANCE SA250401
U95842DYNAL CLASSIC-SSP HLA B17*REF DYN 591.02DYNAL FRANCE SA250401
U95852DYNAL CLASSIC-SSP HLA B18*REF DYN587.02DYNAL FRANCE SA250401
U95872DYNAL CLASSIC-SSP HLA B8*REF DYN 584.02DYNAL FRANCE SA250401
U95252HEMATIES TEST A 2 % POUR DETECTION DES ANTI-A ET ANTI-B IMMUNS *REF 141617EFS BRETAGNE30501
U91032JEU DE CALIBRATEURS AIA PACK TROPONINE I*REF E06-01-5398EUROGENETICS FRANCE30401
V98962CBC-SYS*REF R. 2K455G/466GHYCEL DIAGNOSTICS140601
V98972CBC-SYS*REF R. 2K456G/461GHYCEL DIAGNOSTICS140601
V98982CBC-SYS*REF R. 2K459G, 457G, 460G, 462G, 464G, 467GHYCEL DIAGNOSTICS140601
V99062ADVIA RETIC PLUS*REF R. 2859G/60G/66GHYCEL DIAGNOSTICS140601
V97842COFFRET D'HEMATIES A1& B MICROMETHODE*REF A1BMIC5/10/50IMMUCOR BELGIUM290501
U95332HEMATIES TESTS A1-, A2+B+ ET O+ 0,8% MICROPLAQUE SERI I*REF 108140153INSTITUT
JACQUES BOY		90401
U95342HEMATIES TESTS A1-, A2+ET B+ 0,8% MICROPLAQUE*REF 108110153INSTITUT
JACQUES BOY		90401
U95352HEMATIES TESTS A1-, A2+ET B+ 0,8 MICROPLAQUE*REF 108110253INSTITUT
JACQUES BOY		90401
U95362HEMATIES TESTS A1-, A2+B+ ET 0+ A 0,8% MICROPLAQUE SERIE II*REF 108140253INSTITUT
JACQUES BOY		90401
U95632EASYWELL ABO/D8 [[ACCENT]]e6PLAQU A/B/A/B/D/D/CT BIRMA1, ES4, ES15, MS201, TH28, MS26, *REF 109081543INSTITUT
JACQUES BOY		90401
U95642EASYWELL ABO/D12 [[ACCENT]]e6PLAQ A/B/AB/D/CT BIRMA1, ES4, ES15, MS201, TH28, MS26, *REF 109081553INSTITUT
JACQUES BOY		90401
U97092ANTI-PETIT E (RH5)/CLONES MS62+MS69/IGM*REF 1020304/-46/-24INSTITUT
JACQUES BOY		260601
V97622GELOSE CLED*REF 220006INTERNATIONAL
MICROBIO		60601
V97632GELOSE CHOCOLAT MICROVEX*REF 220022INTERNATIONAL MICROBIO60601
V98002GELOSE SABOURAUD GENTAMICINE CHLORAMPHENICOL*REF.220015INTERNATIONAL MICROBIO60601
U93222GELOSE CHOCOLAT ISOVITALEX *REF. 12004/12004BLABOBASI120401
U93242MAC CONKEY *REF. 12009/12009BLABOBASI120401
U93342TRYPTICASE SOJA AU SANG DE MOUTON *REF.12037/BLABOBASI120401
U93352TRYPTICASE SOJA *REF.12016/BLABOBASI120401
U97042EU-TTG IGA UMANA*REF 9763MAST DIAGNOSTIC120401
U96632ISEPAMYCINE 30[[ACCENT]]e6G*REF ISP30CMAST DIAGNOSTIC130401
U96742NEOMYCINE 30 [[ACCENT]]e6G*REF NE30CMAST DIAGNOSTIC130401
U96772KANAMYCINE 30[[ACCENT]]e6G*REF K30CMAST DIAGNOSTIC130401
V97402CEFACLOR. 30[[ACCENT]]e6G*REF CFC 30CMAST DIAGNOSTIC160501
U96792CEFPIROME 30[[ACCENT]]e6G*REF CFP30CMAST DIAGNOSTIC180501
V98182TENSIO ACTIF POUR ANALYSEUR TARGA*REF T400MENARINI
DIAGNOSTICS		290501
V98192SOLUTION DE DECONTAMINATION POUR ANALYSEUR TARGA*REF T398MENARINI
DIAGNOSTICS		290501
U96322COFFRET DE REACTIFS POUR STAT PROFILE M*REF 19667/24241/24226NOVA BIOMEDICAL
FRANCE		250401
V98412ORTHO ANTIBODY TO HBSAG ELISA TEST SYSTEM 3 CONFIRMATORY TEST*REF 931860ORTHO CLINICAL
DIAGNOSTICS FRANCE		290501
U942220,8% RESOLVE PANEL B *REF 7195 22ORTHO CLINICAL
DIAGNOSTICS FRANCE		190601
U942320,8% RESOLVE PANEL A *REF 719502ORTHO CLINICAL
DIAGNOSTICS FRANCE		190601
U942520,8% SURGISCREEN *REF719102ORTHO CLINICAL
DIAGNOSTICS FRANCE		190601
U960220,8% AFFIRMAGEN 4*REF 719221ORTHO CLINICAL
DIAGNOSTICS FRANCE		190601
U960320,8% AFFIRMAGEN*REF 719202ORTHO CLINICAL
DIAGNOSTICS FRANCE		190601
U960420,8% AFFIRMAGEN 3*REF 719212ORTHO CLINICAL
DIAGNOSTICS FRANCE		190601
V99432TAMPON DE LAVAGE CONCENTR. 20X*REF 933730ORTHO CLINICAL
DIAGNOSTICS FRANCE		290601
V97702REVELATEST INSTANT GROSSESSE*REF 7657737/43PIERRE FABRE SANTE190601
U90562INDICATEST*REF IG1010/IG1020POLIDIS130401
U93902AMPLICOR HCV DETECTIONKIT V2.O *REF.11 1110 8ROCHE DIAGNOSTICS120401
V97772CFAS TPU-C*REF 2149753ROCHE DIAGNOSTICS300501
V99532DILUENT ESTRADIOL/PROGESTERONE ELECSYS*REF 3028542ROCHE DIAGNOSTICS260601
Attestation
provisoire pour
6 mois		   
U88732SAFETY TEST ABO*REF 79059DIAGAST LABORATOIRES300501
M22792PTU-AB*REF 79054/79062DIAGAST LABORATOIRES140601
U94292CARTE CONTROLE PRETRANSFUSIONNEL *REF 33 90 302ETABLISSEMENT FRANCAIS DU SANG RHONE ALPES140601
R. 51372MEDTRO-KARTE*REF 20/100-200/500-1000MEDTRO GMBH290601
Transfert
d'enregistrement		   
D42460ICON II HCG*REF B01326BECKMAN COULTER FRANCE290601
D74170MRX W.N MEN.B/E.COLI*REF 30859501J2L ELITECH60601
N25582MRX LAP*REF 30168501J2L ELITECH60601
B36770MRX W.S PNEUMONIAE*REF 30859101J2L ELITECH60601
B36780MRX W.H INFLUENZAE B*REF 30858802J2L ELITECH60601
B36790MRX W.N MENI.ACW135*REF 30859201J2L ELITECH60601
D41350MRX STREPTEX ABCDFG*REF 30950501J2L ELITECH60601
D41360MRX STREPTEX LATEX A*REF 30950601J2L ELITECH60601
D41370MRX STREPTEX LATEX B*REF 30950701J2L ELITECH60601
D41380MRX STREPTEX LATEX D*REF 30950901J2L ELITECH60601
D81060MRX EDTA SOLUTION*REF30164501J2L ELITECH60601
D84390MRX ROTAVIRUS LATEX TEST*REF 309500401J2L ELITECH60601
F08261MRX REVEAL STREP A*REF 30858601J2L ELITECH60601
F08271MRX W.AG BACTERIAL*REF 30859601J2L ELITECH60601
G15641MRX WELLCOLEX SAL. 50/200*REF 30858301/02J2L ELITECH60601
G17950MRX WELLCO SHIG COL*REF 30858401J2L ELITECH60601
J70441MRX PYR (STREP D)*REF30854301J2L ELITECH60601
K86951MRX D-DIMER WELLCO*REF 30852501J2L ELITECH60601
M19042MRX STAPHAUREX PLUS*REF 30950102/201J2L ELITECH60601
M20742MRX PLASMA FDP*REF 30852901J2L ELITECH60601
N27562MRX STREPTEX LATEX C*REF 30950801J2L ELITECH60601
N27572MRX STREPTEX LATEX F*REF 30951101J2L ELITECH60601
N27582MRX STREPTEX LATEX G*REF 30951201J2L ELITECH60601
N27592MRX STREPTEX POLY POSITIVE CTRL*REF 30154601J2L ELITECH60601
P35922MRX WELL.E.COLI 0157*REF 30959501J2L ELITECH60601
S62462MRX WELL.E.COLI H7*REF 30959601J2L ELITECH60601
X04510MRX SAL TYPHI H (D)*REF 30855001J2L ELITECH60601
X04530MRX SAL PARATYP.A-H*REF 30855101J2L ELITECH60601
X04540MRX SAL PARTYP.B-H*REF 30855201J2L ELITECH60601
X04550MRX PARATYPHI C*REF 30952801J2L ELITECH60601
X04560MRX S ENTERIDIS H*REF 30952901J2L ELITECH60601
X04570MRX S NEWPORT H*REF 30953001J2L ELITECH60601
X04580MRX S TYPHIMURIUM H*REF 30953101J2L ELITECH60601
X04590MRX S FALG NON ID*REF 30953201J2L ELITECH60601
X04600MRX SAL TYOHI O 9/12*REF 30855301J2L ELITECH60601
X04610MRX S TYPHI VI O*REF 30953901J2L ELITECH60601
X04620MRX S PARATYPHI AO*REF 30953301J2L ELITECH60601
X04630MRX SAL PARATYP.B-O*REF 30855401J2L ELITECH60601
X04640MRX S PARATYPHI CO*REF 30953401J2L ELITECH60601
Y18980MRX THYMUNE T*REF 30850601J2L ELITECH60601
Y18990MRX THYMUNE M*REF 30850501J2L ELITECH60601
Y19000MRX THROMBO WELLCO*REF 30852601J2L ELITECH60601
Y19010MRX THROMBO LATEX*REF30852301J2L ELITECH60601
Y19030MRX TAMPON GLYCINE*REF 30853101J2L ELITECH60601
Y19040MRX PHYTOHEMGGLUT*REF30852701J2L ELITECH60601
Y19050MRX PHYTOHEMAG.PURIF*REF 30852801J2L ELITECH60601
Y19200MRX TUBES A PRELEVEMENTS*REF 30853001J2L ELITECH60601
Y36810MRX WELLCOGE.STREP B*REF 30164401J2L ELITECH60601