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BIOMERIEUX INC

VIDAS · Hematology

510(k): 23 Recall: 10 UDI: 0 MAUDE: 10 Class.: 56

510(k) Clearances (23)

VIDAS TBI (GFAP, UCH-L1)
2024-05-01

Substantially Equivalent

VIDAS B.R.A.H.M.S. PCT (PCT)
2017-02-23

Substantially Equivalent

VIDAS D-DIMER EXCLUSION II (DEX2)
2012-07-31

Substantially Equivalent

VIDAS TOXO IGG AVIDITY
2011-05-18

Substantially Equivalent

VIDAS CA 15-3 ASSAY
2009-06-22

Substantially Equivalent

VIDAS CA 125 II ASSAY
2009-04-10

Substantially Equivalent

VIDAS RUB IGG
2008-12-23

Substantially Equivalent

VIDAS CEA (S) ASSAY
2008-10-09

Substantially Equivalent

VIDAS AFP ASSAY
2008-09-26

Substantially Equivalent

VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAY
2008-06-11

Substantially Equivalent

VIDAS NT-PROBNP ASSAY, MODEL: 30 449
2008-02-29

Substantially Equivalent

VIDAS C. DIFFICILE TOXIN A&B (CDAB) ASSAY, MODEL: 30 118
2007-12-21

Substantially Equivalent

VIDAS TROPONIN I ULTRA (TNIU) ASSAY, MODEL 30 448
2007-12-14

Substantially Equivalent

VIDAS B.R.A.H.M.S. PCT ASSAY
2007-10-11

Substantially Equivalent

VIDAS D-DIMER EXCLUSION ASSAY, MODEL 30 442
2004-06-10

Substantially Equivalent

VIDAS D-DIMER NEW (DD2) ASSAY, MODEL 30 442
2003-09-02

Substantially Equivalent

VIDAS TROPONIN I (TNI), MODEL 30 445
2003-06-16

Substantially Equivalent

VIDAS D-DIMER NEW (DD2) ASSAY MODEL#30 442
2002-10-03

Substantially Equivalent

VIDAS TESTOSTERONE (TES), MODEL 30 418
2002-07-18

Substantially Equivalent

VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428
2001-04-24

Substantially Equivalent

VIDAS H. PYLORI IGG (HPY) ASSAY, MODEL 30 192
2000-10-04

Substantially Equivalent

VIDAS TOXO IGG II (TXG) ASSAY MODEL 30 210
2000-05-22

Substantially Equivalent

VIDAS PROESTERONE (PRG) (30 409)
1997-01-09

Substantially Equivalent

Recalls (10)

VIDAS PRG Progesterone, REF 30409-01
2021-09-22

bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.

VIDAS Clostridium Difficile Toxin A&B, CDAB,REF 30118-01
2021-09-22

bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.

VIDAS Clostridium Difficile GDH, REF 30125-01
2021-09-22

bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.

VIDAS DEX@, Dimer Exclusion II, REF 30455-01
2021-09-22

bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.

VIDAS B.R.A.H.M.S. PROCALCITONIN PCT, REF 30450-01
2021-09-22

bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.

VIDAS Mumps IgG (MPG), REF 30218
2021-09-22

bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.

VIDAS Measles IgG (MSG), REF 30219
2021-09-22

bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.

VIDAS TOXO IgG Avidity (TXGA), REF 30222-01
2021-09-22

bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.

VIDAS RUB IgG (RBG), REF 30226
2021-09-22

bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.

VIDAS Lyme IgG and IgM LYT, Ref #30 298, containing 60 LYT STR (reagent strip labels), 2 x 30 LYT SPR (Solid Phase Receptable) pouches, 1 x 1.5 ml LYT C1 (human) (positive control bottle), 1 x 1.5 ml LYT C2 (human) (negative control bottle), and 1 x 1.5 ml LYT S1 (human) (standard bottle). The re
2003-10-28

Kit may contain incorrect components

MAUDE Adverse Events (10)

Malfunction
20010613
Malfunction
20010511
Malfunction
20010322
Malfunction
20010321
Malfunction
20010321
Malfunction
20010319
Malfunction
20010312
Malfunction
20010228
Malfunction
20010125
Malfunction
20000809

FDA Classification (56)

Assay, Heparin

Hematology

Adamts13 Activity Test System

Hematology

Stain, Papanicolau

Hematology

Tablet, Resazurin

Hematology

Solution, Silver Carbonate

Hematology

Ethyl Eosin

Hematology

Lymphocyte Separation Medium

Hematology

Microscope, Automated, Image Analysis, Operator Intervention

Hematology

Test, Sickle Cell

Hematology

Nigrosin

Hematology

Control, Platelet

Hematology

Oxyhemoglobin

Hematology

Plasma, Coagulation Control

Hematology

Indigocarmine

Hematology

Antithrombin Iii Quantitation

Hematology

Dna-Probe, B And T Lymphocyte

Hematology

Stains, Chemical Solution

Hematology

Neutral Red

Hematology

Reagent, Schiff

Hematology

Reagent, Russel Viper Venom

Hematology

Romanowsky Stains

Hematology

Centrifuge, Microsedimentation

Hematology

Giemsa Stain

Hematology

Adenine Nucleotide Quantitation

Hematology

Stains, Microbiologic

Hematology

Separator, Automated, Blood Cell, Diagnostic

Hematology

Centrifuge, Cell-Washing, Automated For Immuno-Hematology

Hematology

Analyzer, Chromosome, Automated

Hematology

Immunohistochemistry Reagents And Kits

Hematology

Products, Red-Cell Lysing Products

Hematology

Carbol Fuchsin

Hematology

Counter, Differential Cell

Hematology

Control Material, Blood Circulating Epithelial Cancer Cell

Hematology

Hemoglobinometer

Hematology

Crystal Violet For Histology

Hematology

Warmer, Blood, Non-Electromagnetic Radiation

Hematology

System, Automated Platelet Aggregation

Hematology

Whole Blood Hemoglobin Determination

Hematology

Jenner Stain

Hematology

Red-Cell Count By Photometry

Hematology

Stains, Heinz Body

Hematology

Fluid, Diluting, Red-Cell

Hematology

Reagent, Thromboplastin And Control

Hematology

Hematoxylin, Chrome Alum

Hematology

Reagent & Control, Partial Thromboplastin Time

Hematology

Hemoglobin For Donor Testing

Hematology

Carmine

Hematology

Bothrops Atrox Reagent

Hematology

Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System

Hematology

Auramine O

Hematology

Assay, Glycosylated Hemoglobin

Hematology

Mucicarmine

Hematology

Control, Hemoglobin

Hematology

Red-Cell Indices, Measured

Hematology

Blood Establishment Computer Software And Accessories

Hematology

Van Gieson'S Picro-Fuchsin

Hematology