Bulletin Officiel n°2003-23Agence française de sécutité sanitaire
des produits de santé

Liste au 21 mai 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 premier trimestre 2003, des réactifs de biologie médicale dans le cadre du décret 96-351 du 19 avril 1996

AG 6
1584

NOR : SANG0330209K


(Texte non paru au Journal officiel)

(Voir tableau pages suivantes.)

N°
AFSSAPS		NOM COMMERCIALDISTRIBUTEURDATE
d'attestation
W04503CALIBRATEUR IMX T3 LIBRE*REF 7B18-02ABBOTT DIAGNOSTIC09/01/03
W04513CONTROLES IMX T3 LIBRE*REF 7B18-12ABBOTT DIAGNOSTIC09/01/03
W03383ALLERGENES ALIMENTS I-F1, F25, F26, F31, F45/ADV CENTAUR*REF123616/6303/6704/6706/6712BAYER DIAGNOSTICS - DPT AMES.03/01/03
W03393POLLENS GRAMINEES III-G5, G9, G10, G14, G17 ADV CENTAUR*REF123657/6734/3725/6728/3730BAYER DIAGNOSTICS - DPT AMES.03/01/03
W03643ALLERGENES PROFESSIONNELS K77, K79, K82, K87/ADVIA CENTAUR*REF 126748/50-123642-5886BAYER DIAGNOSTICS - DPT AMES.03/01/03
W03653POLLENS D'ARBRES II T1, T2, T10, T11, T19/ADVIA CENTAUR*REF 126762-3672-839/125889-892BAYER DIAGNOSTICS - DPT AMES.03/01/03
W03663POLLENS D'HERBACIII W5, W10, W11, W13, W16*REF 125900/123687-688/126770-773BAYER DIAGNOSTICS - DPT AMES.03/01/03
W03863REACTIF SERA-PAK LIPASE KC*REF 6589/6590BAYER DIAGNOSTICS - DPT AMES.09/01/03
W03353CONTROLE LIPIDE NIVEAU1/ADVIA 1650*REF B03-4766-01BAYER DIAGNOSTICS - DPT AMES.13/01/03
W03363CONTROLE LIPIDE NIVEAU2/ADVIA 1650*REF B03-4767-01BAYER DIAGNOSTICS - DPT AMES.29/01/03
W03373CONTROLE LIPIDE NIVEAU3/ADVIA 1650*REF B03-4768-01BAYER DIAGNOSTICS - DPT AMES.29/01/03
W04453POUSSIÔRES DE MAISON, H1, H2/ADVIA CENTAUR*REF 123661-662BAYER DIAGNOSTICS - DPT AMES.04/02/03
W04443FAMILLE D'ARBRES III, T8, T30, T203, T206, T210/ADVIACENTAUR*REF123676-126768/4/5/6BAYER DIAGNOSTICS - DPT AMES.11/02/03
X04543FAM.POLLENS DES GRAMINEES IV G7/8/11/12/202/ADV.CENT*REF 125883/123658-9/126726-32BAYER DIAGNOSTICS - DPT AMES.17/03/03
X04553FAM. ANIMAUX II E2 E71 E78, E85, E88/ADVIA CENTAUR*REF123835-637/126684-90-94-97BAYER DIAGNOSTICS - DPT AMES.17/03/03
X04563FAM. ALIMENT II- F5, F12, F13, F33, F84/ADVIA CENTAUR*REF 125867/5848/3836/6707/6715BAYER DIAGNOSTICS - DPT AMES.17/03/03
X04663CALIBRATEUR TDM /ADVIA 1650*REF B03-4790-01BAYER DIAGNOSTICS - DPT AMES.19/03/03
X04673CONTROLES TDM 3 NIVEAUX/ADVIA 1650*REF B03-4791-01BAYER DIAGNOSTICS - DPT AMES.19/03/03
X04763REACTIFS PHENYTOINE/ADVIA 1650*REF B01-4775-01BAYER DIAGNOSTICS - DPT AMES.19/03/03
X04753REACTIFS DIGOXINE/ADVIA 1650*REF B01-4769-01BAYER DIAGNOSTICS - DPT AMES.25/03/03
X04773REACTIFS THEOPHYLLINE/ADVIA 1650*REF B01-4772-01BAYER DIAGNOSTICS - DPT AMES.25/03/03
X04813ALLERGENES ALIMENTS IV F9/48/79/82/88/ADVIA CENTAUR*REF 123642/125865-71-78/126714BAYER DIAGNOSTICS - DPT AMES.31/03/03
X04843ALL.FAM.ALIMENTS VI :F6/8/11/14/90 ADVIA CENTAUR*REF123619/126719/125868/72/73/4647BAYER DIAGNOSTICS - DPT AMES.31/03/03
X04863ALLERGENE MOISISSURESII :M4/5/7/9/13 ADVIA CENTAUR*REF 127844/3838/5887/6756/6753BAYER DIAGNOSTICS - DPT AMES.31/03/03
W03983REACTIF PROTEINE C-REACTIVE (C-RP)*REF 969620BECKMAN COULTER FRANCE24/01/03
W04343CALIBRATEUR PROTEINE C-REACTIVE(C-RP)*REF969739BECKMAN COULTER FRANCE24/01/03
V97832IOTEST CD34 FITC-PE-PC5*REF IM1870/1871/2648BECKMAN COULTER FRANCE14/02/03
W03933COULTER CLONE CYTO-STAT T8-FITC ET T8-RD1*REF 6603861/6603848BECKMAN COULTER FRANCE17/03/03
X04613REACTIF OV MONITOR ACCESS*REF 386357BECKMAN COULTER FRANCE19/03/03
X04623CALIBRATEURS OV MONITOR ACCESS*REF 386358BECKMAN COULTER FRANCE19/03/03
W04313LEUKOSURE FLUOROSPHERES*REF 6607124BECKMAN COULTER FRANCE20/03/03
W04323LEUKOSURE ENUMERATION KIT*REF 175621BECKMAN COULTER FRANCE20/03/03
X04733REACTIF CK-MB*REF386371BECKMAN COULTER FRANCE31/03/03
X04743CALIBRATEURS CK-MB*REF386372BECKMAN COULTER FRANCE31/03/03
W04163ANTI-ENDOMYSIAL AB (AEMA) TEST KIT CONJUGUE ANTI-IGA HUMAINES*REF ME 0904BIOMEDICAL DIAGNOSTICS SA17/01/03
W04173ANTI-ENDOMYSIAL AB (AEMA) TEST KIT CONTRÔLE POSITIF AEMA*REF ME 062-ESDBIOMEDICAL DIAGNOSTICS SA17/01/03
W04153ANTI-ENDOMYSIAL AB (AEMA) TEST KIT*REF ME 0648-ESD/0696-ESDBIOMEDICAL DIAGNOSTICS SA21/01/03
W04253COFFRET DRB3*REF101.121-24UBIONOBIS23/01/03
W04273COFFRET DRB5*REF101.123-24UBIONOBIS23/01/03
W04283COFFRET DPB1*REF101.311-24UBIONOBIS23/01/03
W04303COFFRET DRB4*REF101.122-24UBIONOBIS23/01/03
W03523HHV-6 IGG-IFA*REF V3HHV-6BIOTRIN INTERNATIONAL17/03/03
V01483KAT-QUICK MALARIA TEST*REF KT2/KT25DMI DEVELOPPEMENT13/01/03
W04093DYNAL ALLSET+ SSP DPB1*REF DYN 57821DYNAL BIOTECH SA28/02/03
W03693ANTI-S(MNS3)/CLONE P3S13JS123 (IGG)*REF 141265/6EFS BRETAGNE11/02/03
W04353ANTI-D (RH1)/CLONES P3 F17+P3G6/IGM+IGG/MICROTECH*REF 141453EFS BRETAGNE11/02/03
W04223ANTI-A(ABO1)/CLONE AY263/MURIN*REF 141439EFS BRETAGNE25/02/03
W04433IH CONTROL. 2*REF EBICH1ETABLISSEMENT FRAN ?AIS DU SANG25/03/03
W04133SOLUTION CAPTURE P DELAVAGE ET DE CONSERVATION DES PLAQUETTES*REF IC PWSS ILIMMUCOR BELGIUM11/02/03
W04183COFFRET D'HA1B 5/10ML*REF ICC1A1BT5/ICC1A1BIMMUCOR BELGIUM17/02/03
W04003LABTYPE SSO DQB1 LOCUS TYPING TEST*REF RSSO-2B1INTERNATIONAL GENETIC TECHNOLOGIES17/03/03
W03853ABOD EUROPAE SERIE1 MICROPL. 530+505/B4B10/517+518/CAZ+LORI+LOR. 15C9*REF HGSRM145B6LABORATOIRES EUROBIO14/02/03
W03833PHENO RH-K EUROLYMP/SERIE 1 OLYMPUS/MS24/SAH/POQ/MS16+21+63/MS56*REF HGSR. 0175LABORATOIRES EUROBIO28/02/03
W04363ABOD EUROPAE MICROP SERIE 2/BIRMA-1/LB2/ES4+ES15/CAZ*REF HGSRM258-B6LABORATOIRES EUROBIO28/02/03
W04413PHEN RH-K EUROPAE MICROP SERIE2/MS273/MS35/MS258+MS80/MS62+MS69/MS56*REFHGSRM264AILABORATOIRES EUROBIO28/02/03
W03613HEMATIES-TEST A1/B FORMULE 1 MICROPLAQUE EUCLONE*REF HHEFL. 144-JA/AE/JD/JCLABORATOIRES EUROBIO20/03/03
W03673PHENO RH-K EUROPAE MICROP SERIE1/MS24/SAH/POQ/MS16+21+63/MS56*REF HGSRM151-A1LABORATOIRES EUROBIO20/03/03
W03843ABOD EUROLYMP SERIE 1/OLYMPUS/530+505/B4B10/517+518/LORI+LOR. 15C9*REF HGSRM169-JFLABORATOIRES EUROBIO20/03/03
W04473AUTION WASH SOLUTION*REF 29072MENARINI DIAGNOSTICS09/01/03
V99012ETALONS SAO2 POUR STATPROFILE PHOX ET PHOX PLUS*REF 22771NOVA BIOMEDICAL FRANCE17/03/03
V99772SOLUTION DE NETTOYAGE(CLEANING AGENT)*REF 11802NOVA BIOMEDICAL FRANCE17/03/03
V99782SOLUTION DE DEPROTEINISATION*REF 12704NOVA BIOMEDICAL FRANCE17/03/03
V99792SOLUTION DE CONDITIONNEMENT PH*REF 23397NOVA BIOMEDICAL FRANCE17/03/03
V99802SOLUTION DE CONDITIONNEMENT NA/PH*REF 06856NOVA BIOMEDICAL FRANCE17/03/03
W02763COFFRET DE REACTIFS POUR STAT PROFILE PHOX CO-OXYMETRE*REF 25055NOVA BIOMEDICAL FRANCE17/03/03
W02773ETALON HBT (HEMOGLOBINE TOTALE) POUR STAT PROFILE CO-OXYMETRE*REF 18100NOVA BIOMEDICAL FRANCE17/03/03
W02783SOLUTION DE DPOUR STAT PROFILE CO-OXYMETRE*REF 18098NOVA BIOMEDICAL FRANCE17/03/03
W02793CONTRâLES QUALITPOUR STAT PROFILE CO-OXYMETRE*REF 18099NOVA BIOMEDICAL FRANCE17/03/03
W03563SERUM DE CONTROLE CRP(LATEX)*REF ODC0013OLYMPUS FRANCE03/01/03
W03573DIGOXINE*REF OSR. 6404OLYMPUS FRANCE17/01/03
X04573CALIBRATEUR DIGOXINE*REF ODC 6404OLYMPUS FRANCE25/03/03
W03243ORTH 0,8% RED CELL DILUENT*REF 718820/25ORTHO CLINICAL DIAGNOSTICS FRANCE13/01/03
W04243CONTROLE HB AFSC*REF 4791SEBIA S.A09/01/03
W04393CONTROLE LP(A)* REF 4776SEBIA S.A09/01/03
W04423CAPILLARYS BETA1-BETA2+*REF2002SEBIA S.A14/01/03
W04463TAMPON CAPILLARYS BETA1-BETA2+*REF 2042SEBIA S.A14/01/03
X04533TAMPON CAPILLARYS BETA1-BETA 2*REF 2041SEBIA S.A29/01/03
W03683SOLUTION ISE 1 N KCI ELECTRODE REF HITACHI 704,717,736,737,747,912,917*REF 20504VR. 2M09/01/03
Attestation de transfert
M20622RENIN III GENERATION*REF RENINECIS BIO INTERNATIONAL13/01/03
N24332ALDOSTERONE RIA-4H*REF ALDO4HCIS BIO INTERNATIONAL13/01/03
H83170THYROGLOBULINE IRMA*REF THYROCIS BIO INTERNATIONAL14/01/03
M21882BI-INSULIN IRMA*REF BI-INS-IRMACIS BIO INTERNATIONAL14/01/03
N35262C-PEPTIDE RIA*REF C-PEPTIDECIS BIO INTERNATIONAL14/01/03
S67842ANTI-INSULINE RIA*REF AAICIS BIO INTERNATIONAL14/01/03
T80882TG AB ONE STEP*REF TGAB I STEPCIS BIO INTERNATIONAL11/02/03
T80892TPO AB ONE STEP*REF TPOAB I STEPCIS BIO INTERNATIONAL11/02/03
R60882HYBRID CAPTURE 2 HPV-DNA*REF 5196-1230DIGEN FRANCE SAS19/02/03
H15690OXALATE*REF 591C/DTRINITY BIOTECH PLC18/03/03
H15700OXALATE URINAIRE CONTROL-E*REF 06502TRINITY BIOTECH PLC18/03/03
H35471HDL CHOLESTEROL CONTROLE-HIGH*REF H5009-10TRINITY BIOTECH PLC18/03/03
H44871HDL CHOLESTEROL CONTROL-LOW*REF H4009-10TRINITY BIOTECH PLC18/03/03
H49051HDL CHOLESTEROL CONTROL-MID*REF H4059-10TRINITY BIOTECH PLC18/03/03
H50471LIPASE-PS*REF 805-ATRINITY BIOTECH PLC18/03/03
H59180OXALATE STANDARDS SET*REF 59111-1TRINITY BIOTECH PLC18/03/03
H59190OXALATE URINE CONTROL-N*REF 06627TRINITY BIOTECH PLC18/03/03
H86090OXALATE STANDARD0.50MMOL/L*REF 5913TRINITY BIOTECH PLC18/03/03
J25230ACE CONTROL-N*REF A6040TRINITY BIOTECH PLC18/03/03
J64881LIPASE-PS KIT*REF 805BTRINITY BIOTECH PLC18/03/03
J66541LACTATE STANDARD SOLUTION*REF 82610TRINITY BIOTECH PLC18/03/03
J66551ACE REAGENT*REF 30510TRINITY BIOTECH PLC18/03/03
J66561LACTATE REAGENT*REF 73510TRINITY BIOTECH PLC18/03/03
J67551LACTATE STANDARDS SET*REF 73511TRINITY BIOTECH PLC18/03/03
J67671ACE CONTROL-E*REF A7040TRINITY BIOTECH PLC18/03/03
L. 89241LIPASE LIN-TROL*REF L. 3025TRINITY BIOTECH PLC18/03/03
M22422ACE CALIBRATOR*REF 30550TRINITY BIOTECH PLC18/03/03
N28462BILE ACID KIT*REF 450ATRINITY BIOTECH PLC18/03/03
N29032BILE ACID CALIBRATOR SET*REF 45011/22TRINITY BIOTECH PLC18/03/03
P40182G-6-PDHCONTROL NORMAL*REF G6888TRINITY BIOTECH PLC18/03/03
P40192G-6-PDHCONTROL DEFICIENT*REF G5888TRINITY BIOTECH PLC18/03/03
P40712CARDIOLIPID CONTROL LEVEL. 1*REF C4571TRINITY BIOTECH PLC18/03/03
P40722CARDIOLIPID CONTROL LEVEL. 2*REF C4696TRINITY BIOTECH PLC18/03/03
R55652EZ HDL CALIBRATORS*REF3545TRINITY BIOTECH PLC18/03/03
R55662EZ HDL CHOLESTEROL*REF354L-A/B/C/DTRINITY BIOTECH PLC18/03/03