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
265

NOR : SANG0330008K


(Texte non paru au Journal officiel)

(Voir tableau pages suivantes.)


AFSSAPS
NOM COMMERCIALDISTRIBUTEURDATE
d'attestation
V01073GELOSE MH GISA*REF 020007-020008I2A08-11-02
V01553CARTOUCHE PT-NC-RAPIDPOINT COAG*REF 118580BAYER DIAGNOSTICS - DPT AMES.27-11-02
W02103SOLUTION ALSEVERS MODIFIEE *REF 806510BIOTEST S.A.R.L.02-12-02
W02213REACTIFS IMMUNOLOGIQUES CELL DYN CD3-4 ET CD3-8*REF 07H22-01ABBOTT DIAGNOSTIC11-10-02
W02833CEFOTAXIME 30 G*REF CTX30CMAST DIAGNOSTIC27-11-02
W02843PRISTINAMYCINE 15 G*REF PRI15CMAST DIAGNOSTIC27-11-02
W02853COLISTINE 50 G*REF CO50CMAST DIAGNOSTIC27-11-02
W02863METRONIDAZOLE 4 G*REF MZ4CMAST DIAGNOSTIC27-11-02
W02873OFLOXACINE 5 G*REF OF5CMAST DIAGNOSTIC27-11-02
W02913GENTAMICINE 15 G*REF GM15CMAST DIAGNOSTIC27-11-02
W03073REACTIFS HOMOCYSTEINE(HCY)/ACS 180 ET ADVIA CENTAUR*REF//124576-575-578-577BAYER DIAGNOSTICS - DPT AMES.14-10-02
W03103AXSYM TSH 3EME GENERATION*REF 5C34-20ABBOTT DIAGNOSTIC22-10-02
W03113CALIBRATEURS STANDARDS AXSYM TSH 3EME GENERATION*REF 5C34-01ABBOTT DIAGNOSTIC22-10-02
W03123CONTROLES AXSYM TSH 3EME GENERATION*REF 5C34-10ABBOTT DIAGNOSTIC22-10-02
W03163BD LINK 2 STREP A* REF 422012BECTON DICKINSON BIOSCIENCES EUROPE08-11-02
W03183STREPA QUICK STICK * REF GSD-141-142-143NEPHROTEK LABORATOIRES08-11-02
W03193REACTIF THEOPHYLLINE 2-ACS180 ET ADVIA CENTAUR*REF 128379-80-77-78BAYER DIAGNOSTICS - DPT AMES.08-11-02
W03203ANTI-B (ABO2)-CLONE LB2-IGM*REF102010244-254-544INSTITUT JACQUES BOY02-12-02
W03233CREATININE*REF OSR. 6178OLYMPUS FRANCE27-11-02
W03273CONTRIL. 7 MULTIPACK*REF 24001380INSTRUMENTATION LABORATORY11-10-02
W03283CONTRIL. 9 MULTIPACK*REF 24001418INSTRUMENTATION LABORATORY11-10-02
W03293REACTIF ACIDE VALPROIQUE-ACS 180 ET ADVIA CENTAUR*REF 1292-16-17-18-19BAYER DIAGNOSTICS - DPT AMES.18-10-02
W03303CALIBRATEUR. 28-ACS 180 ET ADVIA CENTAUR*REF 1292-22-21BAYER DIAGNOSTICS - DPT AMES.18-10-02
W03323HERPES IDENTIFICATION**REF 67-090-67-050ARGENE SA10-10-02
W03333CHOLESTEROL LDL DIRECT-ADVIA 1650*REF B01-4760-01BAYER DIAGNOSTICS - DPT AMES.11-10-02
W03343CHOLESTEROL II HDL DIRECT-ADVIA 1650*REF B01-4757-01BAYER DIAGNOSTICS - DPT AMES.11-10-02
W03423KIT HLA DQB LIFEMATCH*REF 628310BIONOBIS18-12-02
W03433KIT D'IDENTIFICATION AC ANTI-HLA CLASSE I LIFEMATCH*REF 628200BIONOBIS21-11-02
W03473CALIBRATEUR ACCESS MYOGLOBINE*REF 973244BECKMAN COULTER FRANCE11-10-02
W03483ANTI-PETIT E(RH5)-CLONP3G7D-IGM*REF 141205-141206EFS BRETAGNE07-10-02
W03583KIT HLA A LIFE MATCH*REF 628410BIONOBIS18-12-02
W03623COFFRET NOW VRS*REF FR. 59901OXOID18-12-02
W03633COFFRET NOW FLU A ET NOW FLU B*REF FR. 59891OXOID18-12-02
W03703TAMPON TRI-BARBITAL*REF 4500SEBIA S.A17-10-02
W03723IJB-IH CONTROLE 3 *REF 108030357INSTITUT JACQUES BOY02-12-02
W03743CONTRIL. 7 LEVEL. 1 *REF24001381INSTRUMENTATION LABORATORY11-10-02
W03753CONTRIL. 7 LEVEL. 2 *REF24001382INSTRUMENTATION LABORATORY11-10-02
W03763CONTRIL. 7 LEVEL. 3 *REF 24001383INSTRUMENTATION LABORATORY11-10-02
W03773CONTRIL. 9 LEVEL. 1 *REF24001419INSTRUMENTATION LABORATORY11-10-02
W03783CONTRIL. 9 LEVEL. 2 *REF24001420INSTRUMENTATION LABORATORY11-10-02
W03793CONTROL. 9 LEVEL. 3 *REF24001421INSTRUMENTATION LABORATORY11-10-02
W03803COLORANT ROUGE PONCEAU*REF 4550SEBIA S.A17-10-02
W03873HERPES CONSENSUS GENERIQUE - EXTRACTIONARGENE SA10-10-02
W03903HERPES CONSENSUS GENERIQUE - AMPLIFICATIONARGENE SA10-10-02
W03913HERPES CONSENSUS GENERIQUE - REVELATIONARGENE SA10-10-02
W03963CONTROLES LCR-ADVIA 120*REF T03-4485-01BAYER DIAGNOSTICS - DPT AMES.21-11-02
W03973REACTIF LCR-ADVIA 120*REF T01-4610-01BAYER DIAGNOSTICS - DPT AMES.02-12-02
W03993LABTYPE SSO A LOCUS TYPING TEST*REF RSSO-1AINTERNATIONAL GENETIC TECHNOLOGIES18-12-02
W04013LABTYPE SSO B LOCUS TYPING TEST*REF RSSO-1BINTERNATIONAL GENETIC TECHNOLOGIES18-12-02
W04023LABTYPE SSO DRB1 LOCUS TYPING TEST*REF RSSO-2B1INTERNATIONAL GENETIC TECHNOLOGIES18-12-02
W04063HEMATIES TEST A2+, 0+/5 % EPREUVE SERIQUE-SERIE 2*REF 107010659/663/653INSTITUT JACQUES BOY10-12-02
W04073HEMATIES TESTS A1-, B+/5 % EPREUVE SERIQUE-SERIE 2 *REF//107010559-563-553INSTITUT JACQUES BOY10-12-02
W04103HEMATIES TESTS A1-, A2+, B+, O+/2,5%(MICROPLAQUE)SERIE 2*REF//107140253INSTITUT JACQUES BOY10-12-02
W04113HEMATIES TESTS A1-, B+/2,5%(MICROPLAQUE) SERIE 1*REF 107140353//INSTITUT JACQUES BOY10-12-02
W04123HEMATIES TESTS A1-, B+/2,5%(MICROPLAQUE) SERIE 2*REF 107140453//INSTITUT JACQUES BOY10-12-02
W04193HEMATIES TESTS A1-, B+/0,8% POUR L'EPREUVE SERIQUE-MICRO//PLAQUE*REF 108140353INSTITUT JACQUES BOY10-12-02
W04203HEMATIES TESTS A2+, 0+/0,8% EPREUVE SERIQUE-GEL FILTRATION*REF//708040353-63-59INSTITUT JACQUES BOY10-12-02
W04213HEMATIES TESTS A1-, B+/0,8% EPREUVE SERIQUE-GEL FILTRATION*REF708040253INSTITUT JACQUES BOY10-12-02
 Attestation provisoire
K60090REACTIF THROMBINE*REF :880-12/881-12//TRINITY BIOTECH PLC14-10-02
K60100FIBRINOGENE DE REFERENCE*REF 880-10/881-10//TRINITY BIOTECH PLC14-10-02
K60110OWRENS BUFFER*REF 05880TRINITY BIOTECH PLC17-10-02
K82651ACCUCLOT REFER PLASMA*REF A7432TRINITY BIOTECH PLC17-10-02
K82661DOSAGE DU FIBRINOGENE* REF 880-ATRINITY BIOTECH PLC17-10-02
K82681ACCUCLOT* PLASMA DEFICIENT EN PROTEINE C*REF A7807TRINITY BIOTECH PLC14-10-02
K82691ACCUCOLOR PROTEINE S*REF CRS104-ATRINITY BIOTECH PLC14-10-02
K82701CHROMOGENIC PROTEINE C KIT*REF CRS101ATRINITY BIOTECH PLC17-10-02
K82721ACCUCLOT PLASMA DEFICIENT EN PROTEINE S* REF A7932TRINITY BIOTECH PLC14-10-02
K82811ACCUCOLOR PROTEINE C-EID*REF CRS102ATRINITY BIOTECH PLC14-10-02
K82821ACCUCLOT PROTEINE C* REF CRS103ATRINITY BIOTECH PLC14-10-02
L05592ACCUCLOT CONTROL 1*REF A4089TRINITY BIOTECH PLC14-10-02
L05602ACCUCLOT CONTROL 2*REF A5089TRINITY BIOTECH PLC14-10-02
L05612ACCUCLOT CONTROL 3*REF A6089TRINITY BIOTECH PLC14-10-02
L05622ACCUCLOT D-DIMERE*REF.CRS116ATRINITY BIOTECH PLC14-10-02
M22962APTT-FSL*REF A4560/A5435/A0208/A0333/TRINITY BIOTECH PLC17-10-02
N28492FACTOR II DEFICIENT*REF F2DTRINITY BIOTECH PLC14-10-02
N28502FACTOR VII DEFICIENT*REF F7DITRINITY BIOTECH PLC14-10-02
N28512FACTOR VIII DEFICIENT*REF F8D-ITRINITY BIOTECH PLC14-10-02
N28522FACTOR X DEFICIENT*REF F10D-ITRINITY BIOTECH PLC14-10-02
N28652REACTIF APTT-FS*REF A2051/A2176/A9832/A9957//TRINITY BIOTECH PLC14-10-02
N28662ALEXIN REAGENT*REF A1801/A1926//TRINITY BIOTECH PLC14-10-02
N28672PREKALLIKREIN FAC*REF.B6765TRINITY BIOTECH PLC14-10-02
N28682PLASMA DEFICIENT EN KININOGENE DE HAUT POIDS MOLECULAIRE*REF B6640.TRINITY BIOTECH PLC14-10-02
N28692FACTOR V DEFICIENT PLASMA*REF F5D-ITRINITY BIOTECH PLC14-10-02
N28702FACTOR IX DEFICIENT PLASMA*REF F9D-ITRINITY BIOTECH PLC14-10-02
N28792HEPARIN CONTROL LOW*REF*REF H2021TRINITY BIOTECH PLC14-10-02
N28802HEPARIN CONTROL HIGHT*REF H1021TRINITY BIOTECH PLC14-10-02
N29062ATROXINE*REF 8452TRINITY BIOTECH PLC14-10-02
P40692THROMBOPLASTINE-XS*REF T9298-T9423TRINITY BIOTECH PLC14-10-02
P40702THROMBOPLASTINE-HS*REF T4552TRINITY BIOTECH PLC14-10-02
P41022FACTOR XII DEFICIENT*REF F12DTRINITY BIOTECH PLC14-10-02
P41032FACTOR XI DEFICIENT*REF F11DTRINITY BIOTECH PLC14-10-02
P44672ACCUCOLOR HEPARIN KIT*REF CRS106ATRINITY BIOTECH PLC14-10-02
S63742THROMBOMAX WITH CALCIUM*REF T6404/T9902/TRINITY BIOTECH PLC14-10-02
S70512FIBRINOGEN KIT*REF 886A/88610/88612/TRINITY BIOTECH PLC14-10-02
S70522ANTITHROMBIN III*REF CRS117ATRINITY BIOTECH PLC14-10-02
T84142ACCUCOLOR HIGHT CALIBRATOR*REF A3089TRINITY BIOTECH PLC14-10-02
T86782INR CALIBRATOR KIT*REF A6718TRINITY BIOTECH PLC14-10-02