Bulletin Officiel n°2002-7Agence française de sécurité sanitaire
des produits de santé

Liste au 5 février 2002 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 quatrième trimestre

AG 6
540

NOR : MESG0230036K


(Texte non paru au Journal officiel)

(Voir tableaux pages suivantes.)

N°
AFSSAPS		NOM COMMERCIALDITRIBUTEURDATE
d'attestation
U96382LIPA HLA-C*REF K-1073ABBOTT DIAGNOSTIC13-12-01
U96392LIPA HLA-C AMPLIFICATION*REF P-1073ABBOTT DIAGNOSTIC13-12-01
U96612CALIBRATEURS PREALBUMINE ABBOTT*REF 6E57-01ABBOTT DIAGNOSTIC8-10-01
V00233CD22 SANG DE CONTROLE D'HEMATOLOGIE NIVEAU NORMAL*REF 99103ABBOTT DIAGNOSTIC18-12-01
V00243CD26 SANG DE CONTROLE D'HEMATOLOGIE NIVEAU NORMAL*REF 02H44ABBOTT DIAGNOSTIC18-12-01
V00803ABX DIAGNOSTICS HBA1C WB*REF A11A001454ABX DIAGNOSTICS22-11-01
V00813ABX DIAGNOSTICS HBA1C WB CONTROLS*REF A11A001455ABX DIAGNOSTICS22-11-01
V00823ABX DIAGNOSTICS HBA1C WB CALIBRATOR*REF A11A001456ABX DIAGNOSTICS22-11-01
V01103REACTIFS CA 15-3/ADVIA CENTAUR*REF 128535/128534BAYER DIAGNOSTICS - DPT AMES.27-11-01
V01113CALIBRATEUR CA 15-3/ADVIA CENTAUR*REF 128539/128538BAYER DIAGNOSTICS - DPT AMES.27-11-01
V99632VERSANT HCV RNA ASSAYCONTROL SET*REF122235EBAYER DIAGNOSTICS - DPT AMES.20-12-01
V99642VERSANT HCV RNA QUALITATIVE ASSAY*REF122235BAYER DIAGNOSTICS - DPT AMES.20-12-01
V99652VERSANT AUTO DETECT SET*REF122235DBAYER DIAGNOSTICS - DPT AMES.20-12-01
V00843BECKMAN COULTER TRUCOLOR MAY-GRUNWALD STAIN*REF7547200BECKMAN COULTER FRANCE22-11-01
V00853BECKMAN COULTER TRUCOLOR GIEMSA STAIN*REF7547201BECKMAN COULTER FRANCE22-11-01
V01433COULTER LATRON CONTROL*REF 7546914BECKMAN COULTER FRANCE21-12-01
V01443COULTER LATRON PRIMER*REF 7546915BECKMAN COULTER FRANCE21-12-01
V97502IOTEST CD45 FITC/PE/PC5*REFIM0782/IM2078/IM2653BECKMAN COULTER FRANCE18-12-01
V00023COFFRET DRB1*04*REF 10111424UBIONOBIS30-10-01
V00033COFFRET DRB1*03*REF 10111324UBIONOBIS30-10-01
V00043COFFRET DRB1*15/16*REF 10111224UBIONOBIS30-10-01
V99962COFFRET DRB1*01*REF 10111124UBIONOBIS30-10-01
V99972COFFRET DRB1*08/12*REF 10111912UBIONOBIS30-10-01
V99982COFFRET DRB1*07*REF 10111824UBIONOBIS30-10-01
V99992COFFRET DRB1*13*REF 10111624UBIONOBIS30-10-01
V98852CHROMOPEP ATIII 50*REF 50101001BIOPEP S.A.10-10-01
V98862CHROMOPEP ATIII 25*REF 50101000BIOPEP S.A.10-10-01
V00383TOX/SEE MULTI-DRUG SCREEN PANEL*REF 194-5182EXBIO-RAD SA19-12-01
V00793% CDT TIA SET DE CONTROLES*REF 1945309BIO-RAD SA13-12-01
V01363TOX/SEE MULTI-DRUG SCREEN TEST*REF 194-5216BIO-RAD SA19-12-01
V99502% CDT TIA*REF 1945337BIO-RAD SA22-11-01
V01743ERYTYPECELL B*REF 816043BIOTEST S.A.R.L.18-12-01
V01753ERYTYPECELL O*REF 816044BIOTEST S.A.R.L.18-12-01
V01763ERYTYPECELL A1*REF 816041BIOTEST S.A.R.L.18-12-01
V01773ERYTYPECELL A2*REF 816042BIOTEST S.A.R.L.18-12-01
V99572SOLIDSCREEN II STRIP TANGO*REF 806521BIOTEST S.A.R.L.20-12-01
V99592SOLIDSCREEN II CONTROL TANGO*REF 806514BIOTEST S.A.R.L.19-12-01
V98942ELISA LEISHMANIA INFANTUM*REF 9500BORDIER AFFINITY PRODUCTS14-11-01
V00263SELF CLEAR*REF SC-1/SC-2CORE DIAGNOSTICS LTD14-11-01
V97542SYVA RAPIDCUP D.A.U. 5 THC/COC/MAMP/OPI/PCP*REF 6A729DADE BEHRING S.A.4-10-01
V97552SYVA RAPIDCUP D.A.U. 4 THC/COC/MAMP/OPI*REF 6A719DADE BEHRING S.A.4-10-01
V97562SYVA RAPIDCUP D.A.U. 6 AMP/THC/COC/MAMP/OPI/PCP *REF 6A739DADE BEHRING S.A.4-10-01
V99692SYVA RAPIDTEST D.A.U.8*REF 6A269DADE BEHRING S.A.18-12-01
V99702SYVA RAPIDTEST D.A.U.10*REF 6A289DADE BEHRING S.A.17-10-01
V99712SYVA RAPIDTEST D.A.U.9*REF 6A279DADE BEHRING S.A.18-12-01
V00163TEST DE GROSSESSE EUROMEDIS*REF 7482628DECTRA PHARM27-11-01
V98402CARTE ID DIACLON ABO/RH D/PATIENTS (A/B/AB/DVI/DCE/CTL)*REF 001044/43/46/45DIA MED FRANCE7-11-01
V00433ANTI-FYA (FY1)/CLONE DG-FYA-02/IGG*REF 75113DIAGAST LABORATOIRES14-11-01
V00833ELIASCA*REF 69501DIAGAST LABORATOIRES20-12-01
V00183NUCLEOSOME DOT*REF NUD-20DIASORIN S.A27-12-01
V00763INTRINSIC FACTOR+PCA DOT*REF IFPCAD-20DIASORIN S.A27-11-01
V00773NUCLEOSOME+ENA DOT*REF NUENAD-20DIASORIN S.A27-12-01
V99462ANA FLUOR*REF 1624/1660/1662/6624DIASORIN S.A27-11-01
U95822DYNAL CLASSIC-SSP HLA B22*REF DYN 593.02DYNAL FRANCE SA7-11-01
U95862DYNAL CLASSIC-SSP HLA B7*REF DYN 585.02DYNAL FRANCE SA7-11-01
V98792DYNAL CLASSIC-SSP HLA B27 « HIGH RESOLUTION »*REF DYN 57902DYNAL FRANCE SA7-11-01
V97332ANTI-FY A(FY1)/CLONE P3TIM/IGG*REF 141063EFS BRETAGNE14-11-01
V97592TEMOINS POUR RECHERCHE D'AC IRREG ANTI-ERYTHROCYTAIRES(DEPIS/IDENT)*REF 141617EFS BRETAGNE27-11-01
V98012ANTI GRAND E (RH3) CLONES MS80+MS258/IGM*REF 141033/034EFS BRETAGNE8-10-01
V98062ANTI-PETITS (MNS4)/CLONE P3YAN3/IGG*REF 141050EFS BRETAGNE24-10-01
V98952ANTI-LEA(LE1)/CLONE GB1/IGM MURIN*REF 141099/98EFS BRETAGNE4-10-01
V00753KIT TITAN IFE 2000*REF 21016HELENA BIOSCIENCES EUROPE7-12-01
V00713ANTI-E (RH3)/CLONE NATH 110-1D6/IGM*REF 102030383/376INSTITUT JACQUES BOY19-12-01
V98172IJB-IH CONTROLE 1(ABO/D(RH1))*REF 108010157INSTITUT JACQUES BOY24-10-01
V00333IL TEST GEM 1ER. 3000 PAK CARTR :PH, CO2, O2, NA, K, CA, HCT*REF24307507/15007/30007/45007INSTRUMENTATION LABORATORY19-11-01
V00343ILTEST GEM 1ER. 3000 PAK CARTR :PH, CO2, O2, HCT*REF24307504/15004/30004/45004INSTRUMENTATION LABORATORY19-11-01
V00353ILTESTGEM 1ER. 3000 PAKCART :PH, CO2, O2, HCT, NA, K, GLU, LACT*REF24315009/30009/45009INSTRUMENTATION LABORATORY19-11-01
V00203GELOSE CHOCOLAT MICROVEX VCAT*REF 220023INTERNATIONAL MICROBIO17-10-01
V00213GELOSE CHOCOLAT MICROVEX BACITRACINE*REF 220024INTERNATIONAL MICROBIO17-10-01
V00603GELOSE SABOURAUD GLUCOSE*REF 220016INTERNATIONAL MICROBIO17-10-01
V97752ACIDE URIQUE*REF 981391/981788KONELAB6-12-01
U93232GELOSE CHOCOLAT ISOVITALEX+VCAT*REF 12.036/12036BLABOBASI3-12-01
V98802GELOSE CAMPYLOBACTER SELECTIVE*REF 12003/12003BLABOBASI28-11-01
V98812SABOURAUD DEXTROSE AGAR*REF 12031/12031BLABOBASI3-12-01
V98822SABOURAUD DEX+C+GEN*REF 12014/12014BLABOBASI3-12-01
V98842GELOSE BCP*REF 12116/116BLABOBASI3-12-01
V99372GELOSE SS*REF 12.015/BLABOBASI28-11-01
U94342CONTROLE DE SANG TOTALDIRECT CHECK *REF DCJ-N/-ACT-A/-APTT-N/-LRA/-APTT-A/-PT-ALABORATOIRES GAMIDA21-12-01
U93442POLYMYXINE B 300 UNITES *REF. PB300CMAST DIAGNOSTIC12-12-01
U95552AMPICILLINE/ SULBACTAM 20[[ACCENT]]e6G*REF SAM20CMAST DIAGNOSTIC5-12-01
U95592TRIMETHOPRIME 5 [[ACCENT]]e6G*REF TM5CMAST DIAGNOSTIC28-11-01
U95702STREPTOMYCINE 500 [[ACCENT]]e6G*REF S500CMAST DIAGNOSTIC5-12-01
U96222CEFOTIAM 30[[ACCENT]]e6G*REF CTF30CMAST DIAGNOSTIC12-12-01
U96652ENOXACINE 5 [[ACCENT]]e6G*REF ENX5CMAST DIAGNOSTIC5-12-01
U96752MEROPENEME 10[[ACCENT]]e6G*REF MEM10CMAST DIAGNOSTIC12-12-01
V98452CHOLESCREEN*REF 7671335MATARA SARL12-12-01
V98772AUTION CHECK I*REF 24383MENARINI DIAGNOSTICS6-11-01
V98782AUTION CHECK II*REF 24384MENARINI DIAGNOSTICS6-11-01
V994920.8 % RESOLVE PANEL C SYSTEM*REF 719402ORTHO CLINICAL DIAGNOSTICS FRANCE5-11-01
V99662GELOSE OSCM*REF P05136AOXOID14-11-01
V01123ELIA ANA CONTROL*REF 83-1004-01PHARMACIA S.A.S.27-11-01
V98022IMMUNOZYM DIPHTERIE *REF 7702040/7702045PROGEN BIOTECHNIQUE SARL14-11-01
V00863QUALICHECK 4+, NIVEAU 1*REF S7430/944-053RADIOMETER SA7-12-01
V00873QUALICHECK 4+ NIVEAU 2*REF S7440/944-054RADIOMETER SA7-12-01
V00883QUALICHECK 4+ NIVEAU 3*REF S7450/944-055RADIOMETER SA7-12-01
V99212PHOSPHATASE ALCALINE*REF OSR. 6104/6204SCOP GROUPE OLYMPUS21-12-01
V99232PREALBUMINE*REF OSR. 6275SCOP GROUPE OLYMPUS21-12-01
V99102HYDRAGEL BENCE JONES K20*REF 3033/3224SEBIA S.A19-12-01
V99122HYDRAGEL HBA1C K20*REF3011/3211SEBIA S.A30-10-01
V99742CAPILLARYS BETA1-BETA2*REF 2001SEBIA S.A4-10-01

Attestation provisoire pour 6 mois

N°
AFSSAPS		NOM COMMERCIALDITRIBUTEURDATE
d'attestation
U92882SERAFOL ABO*REF BG1704BIOTEST S.A.R.L.12-12-01
M22792PTU-AB*REF 79054/79062DIAGAST LABORATOIRES12-12-01
U88732SAFETY TEST ABO*REF 79059DIAGAST LABORATOIRES12-12-01
R. 51372MEDTRO-KARTE*REF 20/100-200/500-1000MEDTRO GMBH6-11-01

Réactifs contenant des radio-éléments artificiels
Attestation quinquennale

N°
AFSSAPS		NOM COMMERCIALDITRIBUTEURDATE
d'attestation
T80892TPO AB ONE STEP*REF 79492BIO-RAD SA7-12-01
V00083SHIONORIA-BNP*REF IRMA-BNPCIS BIO INTERNATIONAL27-12-01
T84812INSULINE*REF 3210IMMUNOTECH7-12-01
U89452VASOPRESSINE*REF 40-6035NICHOLS INSTITUTE DIAGNOSTICS3-12-01

Attestation de renouvellement

N°
AFSSAPS		NOM COMMERCIALDITRIBUTEURDATE
d'attestation
H49031TANDEM-R PSA*REF 3816/3817.BECKMAN COULTER FRANCE18-12-01
J67201BRESMARQ TANDEM R CA549*REF 3400.BECKMAN COULTER FRANCE18-12-01
N30922TANDEM-R FREE PSA*REF :3818GH.BECKMAN COULTER FRANCE19-12-01
G06141RIA-GNOST PIIIP*REF OCFK07-PIIIPCIS BIO INTERNATIONAL7-12-01
G1900117-OHP-NN*REF 17-OHP-NNCIS BIO INTERNATIONAL7-12-01
G23041DOSAGE IMMUNORADIOMETRIQUE DES AUTO ACANTI-THYROGLOBULINE*REF ELSA-AB-HTG.CIS BIO INTERNATIONAL7-12-01
M17132CORT-CT2 DOSAGE RIA DU-CORTISOL*REF CORT CT2CIS BIO INTERNATIONAL7-12-01
M15032COAT-A-COUNT PROGESTERONE*REF TKPG1/TKPG2.DADE BEHRING S.A.7-12-01
M17262COAT-A-COUNT FSH*REF IKFS1/IKFS2DADE BEHRING S.A.7-12-01
M17292COAT-A-COUNT LH*REF IKLH1/IKLH2DADE BEHRING S.A.7-12-01
M17692COAT-A-COUNT ESTRADIOL-6*REF TKSE1DADE BEHRING S.A.7-12-01
M17702COAT-A-COUNT INSULINE*REF TKIN1/TKIN2DADE BEHRING S.A.7-12-01
M17712COAT-A-COUNT FERRITINE*REF IKFE1DADE BEHRING S.A.7-12-01
M17732COAT-A-COUNT ACE*REF IKCA1/IKCA2DADE BEHRING S.A.7-12-01
M17742COAT-A-COUNT HCG*REF IKCG1/IKCG2/IKCG5DADE BEHRING S.A.7-12-01
M20772DOUBLE ANTICORPS C-PEPTIDE*REF KPED1/KPED2DADE BEHRING S.A.7-12-01
M20782DOUBLE ANTICORPS HGH*REF KGHD1/KGHD2.DADE BEHRING S.A.7-12-01
M22902DOUBLE ANTICORPS GASTRINE*REF KGAD1/KGAD2.DADE BEHRING S.A.7-12-01
C45650SIMULTRAC SNB*REF 06B257117/264806.DIASORIN S.A7-12-01
F14540CYCLO TRAC SP WHOLE BLOOD KIT*REF 23000.DIASORIN S.A7-12-01
L. 01582RENCTK*REF P2721.DIASORIN S.A7-12-01
L. 89371DIRIA-TESTOK*REF P2679DIASORIN S.A7-12-01
L. 94011GASTRINE*REF 06B255017/255025.DIASORIN S.A7-12-01
M11972AB-HTGK-3*REF P000172.DIASORIN S.A7-12-01
M17142ACTH IRMA*REF 27065/27130.DIASORIN S.A7-12-01
P35872FERRITINE MAB RIA KIT*REF 06B160850.DIASORIN S.A7-12-01
P35882FREE T3 RIA KIT*REF 06B258709.DIASORIN S.A7-12-01
P35892HCG-MAB RIA KIT*REF 06B160830/160840.DIASORIN S.A12-12-01
Y12910GAMMACOAT ACTIVE RENINE PLASMATIQUE 125I*REF CA1533/1553.DIASORIN S.A7-12-01
G14761DELTA 4-ANDROSTENEDIONE*REF 0674.IMMUNOTECH7-12-01
G27511DHEA-SULFATE*REF 0729.IMMUNOTECH7-12-01
M16212RIA FT3*REF 1579.IMMUNOTECH7-12-01
N25012HISTAMINE-RIA*REF 1659IMMUNOTECH7-12-01
E00491TK-REA*REF 324250NICHOLS INSTITUTE DIAGNOSTICS12-12-01
L. 89741IRMA-MAT CA-125 II*REF324210NICHOLS INSTITUTE DIAGNOSTICS12-12-01
G17421T4 LIBRE AMERLEX-MAB*REF IM 5051/5054ORTHO CLINICAL DIAGNOSTICS FRANCE12-12-01

Attestation de transfert

N°
AFSSAPS		NOM COMMERCIALDITRIBUTEURDATE
d'attestation
V98392BETA CLEAR HCG*REF 050/025CORE DIAGNOSTICS LTD14-11-01
T79812AG ELECTROSYNERESE DISTOMATOSE SR. 2B*REF 5398SR. 2B27-11-01
T79822AG ELECTROSYNERESE HYDATIDOSE SR. 2B*REF 5400SR. 2B27-11-01
T79842AG ELECTROSYNERESE AMIBIASE SR. 2B*REF 5394SR. 2B27-11-01