Bulletin Officiel n°2003-5Agence française de sécurité sanitaire
des produits de santé

Liste au 14 janvier 2003 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 2002, des réactifs destinés aux analyses de biologie médicale dans le cadre du décret n° 96-351 du 19 avril 1996

AG 6
266

NOR : SANG0330009K


(Texte non paru au Journal officiel)

(Voir tableau pages suivantes.)

N°
AFSSAPS		NOM COMMERCIALDISTRIBUTEURDATE
d'attestation
V01183COFFRET REACTIFS AEROSET PHENOBARBITAL*REF 1E09-01ABBOTT DIAGNOSTIC09-07-02
V01193CALIBRATEURS AEROSET PHENOBARBITAL*REF 6E89-01ABBOTT DIAGNOSTIC09-07-02
V01203COFFRET REACTIFS AEROSET THEOPHYLLINE*REF 1E09-01ABBOTT DIAGNOSTIC09-07-02
V01213CALIBRATEURS AEROSET THEOPHYLLINE*REF 6E89-01ABBOTT DIAGNOSTIC09-07-02
V01223COFFRET REACTIF AEROSET CARBAMAZEPINE*REF 1E12-01ABBOTT DIAGNOSTIC09-07-02
V01233CALIBRATEURS AEROSET CARBAMAZEPINE*REF 6E90-01ABBOTT DIAGNOSTIC09-07-02
W03133HEMA CQI*REF 59500DIAGAST LABORATOIRES09-07-02
V01063ALLER TROL*REF ALLER TROLLABBO IMMUNOSYSTÔMES12-07-02
W02823ANTI-PETIT S(MNS4)-CLOP3YAN3-IGG*REF 78513DIAGAST LABORATOIRES12-07-02
V01493CARTOUCHE A PTT-RAPIDPOINT COAG*REF 118590BAYER DIAGNOSTICS - DPT AMES.18-07-02
V01523CARTOUCHE HMT-RAPIDPOINT COAG*REF 118599BAYER DIAGNOSTICS - DPT AMES.18-07-02
V01563CARTOUCHE PT-ONE-RAPIDPOINT COAG*REF 118570BAYER DIAGNOSTICS - DPT AMES.18-07-02
W02173THYROGLOBULIN ANTIBODY CALIBRATEURS ACCESS*REF 33895BECKMAN COULTER FRANCE18-07-02
W02183THYROGLOBULIN ANTIBODY (TGAB) ACCESS*REF 33890BECKMAN COULTER FRANCE18-07-02
W02723TDX-TDXFLX CORTISOL KIT * REF 9116-65ABBOTT DIAGNOSTIC18-07-02
W02733TDX-TDXFLX CORTISOL CALIBRATEURS * REF 9116-05ABBOTT DIAGNOSTIC18-07-02
W02743TDX-TDXFLX CORTISOL CONTROLES * REF 9116-15ABBOTT DIAGNOSTIC18-07-02
W02953ORTHO TRAK-C ASSAY UREA*REF 933230ORTHO CLINICAL DIAGNOSTICS FRANCE18-07-02
W02963ORTHO TRAK-C ASSAY STANDARD AND CONTROL PACK*REF 933090ORTHO CLINICAL DIAGNOSTICS FRANCE18-07-02
W02933ORTHO TRAK-C ASSAY*REF 933210ORTHO CLINICAL DIAGNOSTICS FRANCE19-07-02
W02943ORTHO TRAK-C ASSAY 20X WASH BUFFER CONCENTRATE*REF 933732ORTHO CLINICAL DIAGNOSTICS FRANCE19-07-02
V98202IOTEST CD4 PC5*REF IM2636BECKMAN COULTER FRANCE31-07-02
V98342IOTEST CD3 PC5*REF IM2636BECKMAN COULTER FRANCE31-07-02
V98352IOTEST CD19 PC5*REFIM 2643BECKMAN COULTER FRANCE31-07-02
W03083DILUANT HCY-ACS 180 ET ADVIA CENTAUR*REF 124554-81BAYER DIAGNOSTICS - DPT AMES.01-08-02
W03093CALIBRATEUR HCY-ACS 180 ET ADVIA CENTAUR*REF 124580-79BAYER DIAGNOSTICS - DPT AMES.01-08-02
W02763COFFRET DE REACTIFS POUR STAT PROFILE PHOX CO-OXYMETRE*REF 25055NOVA BIOMEDICAL FRANCE02-08-02
W02783SOLUTION DE DPOUR STAT PROFILE CO-OXYMETRE*REF 18098NOVA BIOMEDICAL FRANCE02-08-02
V98482GEM TEST ACT CARTRIDGES*REF 6260038000INSTRUMENTATION LABORATORY06-08-02
V99312TEST CORTEZ INSTASTRIP BENZODIAZEPINES*REF3137-05PRETORY SA06-08-02
W02563LYPHOCHEK FERTILITY CONTROL TAUX 1 * REF 481BIO-RAD SA08-08-02
W02573LYPHOCHEK FERTILITY CONTROL TAUX 2 * REF 482BIO-RAD SA08-08-02
W02583LYPHOCHEK FERTILITY CONTROL TAUX 3 * REF 483BIO-RAD SA08-08-02
W02633HAEMOLISANT 60 H DIABETES MODE*REF 31258MENARINI DIAGNOSTICS13-08-02
W02643HAEMOLISANT 60 H DIABET- THALAS- SCREEN MODE*REF 31263MENARINI DIAGNOSTICS13-08-02
W02653ELUENT 60 A DIABETES MODE*REF 31255MENARINI DIAGNOSTICS13-08-02
W02663ELUENT 60 B DABETES MODE*REF 31256MENARINI DIAGNOSTICS13-08-02
W02673ELUENT 60 C DIABETES MODE*REF 31257MENARINI DIAGNOSTICS13-08-02
W02683ELUENT 60 A DIABET & THALAS SCREEN MODE*REF 31259MENARINI DIAGNOSTICS13-08-02
W02693ELUENT 60 B DIABET & THALAS SCREEN MODE*REF 31260MENARINI DIAGNOSTICS13-08-02
W02703ELUENT 60 C DIABET & THALAS SCREEN MODE*REF 31261MENARINI DIAGNOSTICS13-08-02
W02713ELUENT 60 C DIABET & THALAS SCREEN MODE*REF 31261MENARINI DIAGNOSTICS13-08-02
W01933ANTI-AB CLONES BIRMA-1+ES-15+ES-4-MURIN-MICROLONE*REF 711518ORTHO CLINICAL DIAGNOSTICS FRANCE22-08-02
W02413REVELATEST INSTANT OVULATION*REF 156199PIERRE FABRE SANTE22-08-02
W03313CAPICLEAN*REF 2051SEBIA S.A22-08-02
W03443SERUM DE CONTROLE HYPERGAMMA*REF4787SEBIA S.A22-08-02
W03143SALMONELLA LATEX TEST*REF FT0203AOXOID28-08-02
W03153DRYSPOT PNEUMO*REF DR. 0420MOXOID28-08-02
W03263IMMUNOTROL LOW CELLS*REF 6607098BECKMAN COULTER FRANCE28-08-02
W02233CALIBRATEUR MYOGLOBINE* REF ODR. 3025OLYMPUS FRANCE05-09-02
W03043REACTIFS PTH INTACTE-ACS 180 ET ADVIA CENTAUR*REF 129500-499-502-501BAYER DIAGNOSTICS - DPT AMES.05-09-02
W03053CALIBRATEUR PTH INTACTE-ACS 180 ET ADVIA CENTAUR*REF 130198BAYER DIAGNOSTICS - DPT AMES.05-09-02
W03063CONTROLES PTH INTACTE-ACS 180 ET ADVIA CENTAUR*REF 129863BAYER DIAGNOSTICS - DPT AMES.05-09-02
W03403C.PEPTIDE*REF 3639IMMUNOTECH05-09-02
W02093DILUANT MANUEL ARCHITECT T3 TOTALE*REF 6C51-50ABBOTT DIAGNOSTIC10-09-02
W02753SOLUTION COLORANTE HEMOGLOBINE FOETALE TECHNIQUE KLEINHAUSER-SHEPARD*REF CL. 61036LABO-MODERNE10-09-02
W03533REACTIF AXSYM AG-AC VIH COMBO*REF 2G83-20ABBOTT DIAGNOSTIC10-09-02
W03543CONTROLES AXSYM AG-AC VIH COMBO *REF 2G83-11ABBOTT DIAGNOSTIC10-09-02
W03553CONTROLES AXSYM AG-AC VIH COMBO *REF 2G83-12ABBOTT DIAGNOSTIC10-09-02
W02493GELOSE SALMONELLA-SHIGELLA*REF 220007INTERNATIONAL MICROBIO17-09-02
W02883STAPHYCHROM II*REF 22709INTERNATIONAL MICROBIO17-09-02
W02993REACTIFS INSULINE -ACS 180 ET ADVIA CENTAUR*REF 128431-434BAYER DIAGNOSTICS - DPT AMES.17-09-02
W03003DILUANT INSULINE-ACS 180 ET ADVIA CENTAUR*REF 129885BAYER DIAGNOSTICS - DPT AMES.17-09-02
W03013CALIBRATEUR INSULINE-ACS 180 ET ADVIA CENTAUR*REF 128433BAYER DIAGNOSTICS - DPT AMES.17-09-02
W03023REACTIFS PEPTIDE C SERIQUE-ACS 180 ET ADVIA CENTAUR*REF 129024-26BAYER DIAGNOSTICS - DPT AMES.17-09-02
W03033CALIBRATEUR PEPTIDE C SERIQUE-ACS 180 ET ADVIA CENTAUR*REF 129021BAYER DIAGNOSTICS - DPT AMES.17-09-02
W03253KIT ANCA+GBM PROFILE TECHNIQUE DOT*REF 804010120INSTITUT JACQUES BOY17-09-02
V01533RAPID QC PT-NC 2-RAPIDPOINT COAG*REF 119152BAYER DIAGNOSTICS - DPT AMES.23-09-02
V01543RAPID QC PT-NC 1-RAPIDPOINT COAG*REF 118586BAYER DIAGNOSTICS - DPT AMES.23-09-02
V01573RAPID QC PT 1-RAPIDPOINT COAG*REF 118576BAYER DIAGNOSTICS - DPT AMES.23-09-02
V01583RAPID QC PT 2-RAPIDPOINT COAG*REF 119151BAYER DIAGNOSTICS - DPT AMES.23-09-02
V01593RAPID QC APTT 2-RAPIDPOINT COAG*REF 119153BAYER DIAGNOSTICS - DPT AMES.23-09-02
V01603RAPID QC APTT 1-RAPIDPOINT COAG*REF 118595BAYER DIAGNOSTICS - DPT AMES.23-09-02
W02803ANTI-PETIT S (MNS4)-CLONE P3BER IGM[[ACCENT]]e6REF 141271-141270EFS BRETAGNE12-07-02
W03463REACTIF ACCESS MYOGLOBINE*REF 973243BECKMAN COULTER FRANCE23-09-02
W03603IL TEST HDL CHOLESTEROL*REF 182551-40INSTRUMENTATION LABORATORY23-09-02
W03413OLYMP ABO*REF 72410DIAGAST LABORATOIRES23-09-02

Attestation provisoire pour 6 mois
M22792PTU-AB*REF 79054-79062DIAGAST LABORATOIRES09-07-02
U88732SAFETY TEST ABO*REF 79059DIAGAST LABORATOIRES09-07-02

Attestation de transfert
T82932PROCLEIX HIV-1-HCV ASSAY*REF 301098E-99ECHIRON BLOOD TESTING IRELAND12-07-02
T82942PROCLEIX HIV-1 AND HCV EXTERNAL QUALITY CONTROLS*REF 301035ECHIRON BLOOD TESTING IRELAND12-07-02
T82952PROCLEIX ASSAYS FLUIDS*REF 301027CHIRON BLOOD TESTING IRELAND12-07-02
T88682PROCLEIX AUTO DETECT REAGENTS*REF 301121CHIRON BLOOD TESTING IRELAND12-07-02
T88692PROCLEIX HIV-1-HCV DISCRIMINATORY PROBE REAGENTS*REF 301026ECHIRON BLOOD TESTING IRELAND12-07-02
T88702PROCLEIX HIV-1-HCV ASSAY CALIBRATORS*REF 301036ECHIRON BLOOD TESTING IRELAND12-07-02