Atlas FDA

LIQ

33 FDA 510(k) clearances · Product code

124 daysmedian time to decision
276 days90th percentile
33clearances measured

FDA profile

Official device name
Enzyme Linked Immunoabsorbent Assay, Rotavirus
Device class
Class I (low risk)
Regulation
21 CFR 866.3405
Medical specialty
Microbiology
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RecordFirmDate
SAS ROTA TEST (K990842)Sa Scientific, Inc.1999-08-09
VIDAS ROTAVIRUS (RTV) ASSAY (K972895)Biomerieux Vitek, Inc.1997-10-03
IMMUNOCARD STAT! ROTAVIRUS (K971585)Meridian Diagnostics, Inc.1997-08-20
ROTAVIRUS EIA (K964424)Trinity Biotech, Inc.1997-08-08
VIDAS ROTAVIRUS ASSAY (K965092)Biomerieux Vitek, Inc.1997-05-05
ROTA-DAN RAPID ROTAVIRUS EIA KIT (K951208)Eldan Technologies, Ltd.1996-02-14
DIARLEX ROTA-ADENO (K942286)Orion Diagnostica, Inc.1994-12-14
IMMUNOCARD ROTAVIRUS (K933587)Meridian Diagnostics, Inc.1994-02-03
IDEIA(TM) ROTAVIRUS (K932384)Dako Diagnostics , Ltd.1993-12-27
KALLESTAD ROTAVIRUS MICROPLATE (K915137)Bio-Rad Laboratories, Inc.1992-03-04
DAKO ELISA ROTAVIRUS KIT- 96 TESTS K440 (K912666)Dako Corp.1992-02-14
SLIDEX ROTA-KIT 2 (K895805)Vitek Systems, Inc.1991-02-26
ROTACUBE (K884017)Difco Laboratories, Inc.1989-01-24
ORTHO* ROTAVIRUS ANTIGEN ELISA TEST (K883935)Ortho Diagnostic Systems, Inc.1989-01-04
ORTHO* ROTAVIRUS LATEX AGGLUTINATION TEST (K883940)Ortho Diagnostic Systems, Inc.1989-01-04
RESUBMITTED ABBOTT TESTPACK ROTAVIRUS (K880821)Abbott Laboratories1988-05-06
ABBOTT TESTPACK ROTAVIRUS POSITIVE CONTROL (K874375)Abbott Laboratories1987-12-10
ROTASCREEN EIA (K873740)Mercia Diagnostics , Ltd.1987-11-27
ROTA-STAT (K864811)Intl. Diagnostic Laboratories, Ltd.1987-08-25
WELLCOZYME ROTAVIRUS WZ01 (K861628)Wellcome Diagnostics1987-01-21
THE WELLCOME ROTAVIRUS LATEX TEST ZL40 (K861634)Wellcome Diagnostics1986-10-29
PATHFINDER ROTAVIRUS CHEMILUMINESCENT (K862917)Kallestad Laboratories, Inc.1986-10-22
ROTAVIRUS LATEX AGGLUTINATION ASSAY (K861172)Bartels Immunodiagnostic Supplies, Inc.1986-07-01
ROTALEX (K860529)Orion Corp.1986-03-04
ROTALEX 2 LATEX AGGLUTINATION TEST FOR ROTAVIRUS (K854129)Orion Diagnostica, Inc.1986-01-21
PATHFINDER DIRECT ANTIGEN DETECTION SYS ROTAVIRUS (K853554)Kallestad Laboratories, Inc.1985-11-26
VIROGEN ROTATEST SLIDE TEST (K853399)Armkel, LLC1985-11-12
ROTACLONE ROTAVIRUS DIAGNOSTIC KIT (K852969)Cambridge Bioscience Corp.1985-11-05
MERITEC-TOTAVIRUS LATEX DETECTION PROCEDURE (K850269)Meridian Diagnostics, Inc.1985-07-18
ROTAVIRUS ENZYME IMMUNOASSAY (K843367)Intl. Diagnostic Laboratories, Ltd.1985-06-13
ENZYGNOST ROTAVIRUS AG (K841243)Behring Diagnostics, Inc.1984-10-17
ROTALEX LATEX AGGLUTINATION TEST (K841319)Orion Diagnostica, Inc.1984-09-14
ROTAVIRUS BIO-ENZABEAD SCREEN KIT (K834443)Litton Bionetics1984-03-16

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Every clearance here is in the API, with alerts when new ones post.