Atlas FDA

LJC

67 FDA 510(k) clearances · Product code

105 daysmedian time to decision
302 days90th percentile
67clearances measured

FDA profile

Official device name
Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)
Device class
Class I (low risk)
Regulation
21 CFR 866.3120
Medical specialty
Microbiology
Flags
Third-party review eligible
Adverse events (MAUDE)
1996: 1 · 2001: 2 · 2003: 18
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
CT OIA (K032330)Thermo Biostar, Inc.2004-03-02
IDEIA PCE CHLAMYDIA (K033865)Dakocytomation, Ltd.2004-01-21
CHLAMYDIA IGG ELISA TEST SYSTEM (K033079)Trinity Biotech USA2003-11-26
MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIA (K982210)Dade Behring, Inc.1998-07-09
CHLAMYDIA IGG ELISA TEST SYSTEM (K962558)Armkel, LLC1997-02-24
ACCESS CHLAMYDIA ASSAY (K960850)Bio-Rad Laboratories, Inc.1997-02-04
VIDAS CHLAMYDIA BLOCKING ASSAY (K955627)Biomerieux Vitek, Inc.1996-10-07
IMX SELECT CHLAMYDIA (K936054)Abbott Laboratories1996-05-30
IDEIA(TM) CHLAMYDIA BLOCKING REAGENTS, MODIFICATION (K940564)Dako Diagnostics , Ltd.1996-01-11
CHLAMYDIA OIA (K951010)Biostar, Inc.1995-10-07
QUICKVUE(R) CHLAMYDIA TEST (K946276)Quidel Corp.1995-05-19
ACCESS(R) CHLAMYDIA EIA AND BLOCKING ASSAY (K935807)Bio-Rad Laboratories, Inc.1995-05-19
CHLAMYDIA MICROPLATE EIA, CHLAMYDIA MICROPLAE EIA BLOCKING ASSAY (K935393)Bio-Rad Laboratories, Inc.1994-09-20
SYVA MICROTRAK(R) II CHLAMYDIA EIA BLOCK REAGENT (K926090)Syva Co.1993-09-30
MICRO TRAK XL SYSTEM (K921747)Syva Co.1992-10-01
SYVA MICROTRAK CHLAMYDIA EIA (K920503)Syva Co.1992-09-25
MICROTRAK(R) II CHLAMYDIA EIA ASSAY (K921462)Syva Co.1992-09-25
ORTHO CHLAMYDIA ANTIGEN ELISA TEST (K921321)Ortho Diagnostic Systems, Inc.1992-08-11
SEROELISA(TM) CHLAMYDIA IGA TEST KIT (K914327)Savyon Diagnostics , Ltd.1992-06-09
SEROLISA CHLAMYDIA IGG TEST KIT (K915281)Savyon Diagnostics , Ltd.1992-03-23
VIDAS CHLAMYDIA ASSAY, MODIFICATION (K915884)Vitek Systems, Inc.1992-03-04
ANTIGENZ CHLAMYDIA (K912680)Baxter Diagnostics, Inc.1991-07-22
VIDAS CHLAMYDIA ASSAY VITEK IMMUNDIAG ASSAY SYST (K905787)Vitek Systems, Inc.1991-04-29
CIBA CORNING MAGIC LITE CHLAMYDIA IMMUNOASSAY (K904189)Ciba Corning Diagnostics Corp.1991-03-27
ORTHO* CHLAMYDIA ANTIGEN ELISA TEST/MODIFICATION (K910668)Ortho Diagnostic Systems, Inc.1991-03-19
SYVA MICROTRAK CHLAMLYDIA EIA, MODIFICATION (K905179)Syva Co.1991-03-12
CHLAMYDIA SYSTEM SOFTWARE (CSS) (K904725)Kallestad Diag, A Div. of Erbamont, Inc.1991-01-14
ORTHO CHLAMYDIA ANTIGEN ELISA/ELISA CULT EXTRA BUF (K903132)Ortho Diagnostic Systems, Inc.1990-12-21
QUIDEL CHLAMYDIA POSITIVE CONTROL (K903765)Quidel Corp.1990-10-02
SYVA MICROTRAK EIA ACCESSORY REAGENTS (K903758)Syva Co.1990-09-12
ADD'L CLAIMED INTENDED USE FOR IDEIA(TM) CHLAMYDIA (K901972)Novo Nordisk Diagnostics, Ltd.1990-09-05
CIBA CORNING MAGIC LITE CHLAMYDIA IMMUNOASSAY (K902270)Ciba Corning Diagnostics Corp.1990-07-31
QUIDEL CHLAMYDIA TEST (K901660)Quidel Corp.1990-07-27
PATHFINDER(TM) CHLAMYDIA MICROPLATE KIT (K902253)Kallestad Diag, A Div. of Erbamont, Inc.1990-07-26
KODAK SURECELL(TM) CHLAMYDIA CONTROL FLUID SET (K901934)Eastman Kodak Company1990-06-20
VISUWELL(R) CHLAMYDIA (K900973)Adi Diagnostics, Inc.1990-05-15
CHLAMYDIAZYME DIAGNOSTIC KIT (K900543)Abbott Laboratories1990-05-03
ORGENICS IMMUNOCOMB(TM) CHLAMYDIA TRACHOMATIS IGG (K895468)Orgenics, Ltd.1990-03-13
ADD'L USES FOR THE KODAK SURECELL CHLAMYDIA KIT (K900402)Eastman Kodak Company1990-03-08
MODIFIED ELISA FOR CHLAMYDIA (K896032)Fairleigh Dickinson Laboratories, Inc.1990-01-29
CLEARVIEW CHLAMYDIA (K895280)Unipath , Ltd.1990-01-29
KODAK SURECELL CHLAMYDIA TEST KIT (ADD'L USES) (K895505)Eastman Kodak Company1990-01-02
CIBA CORNING MAGIC LITE CHLAMYDIA IMMUNOASSAY (K895122)Ciba Corning Diagnostics Corp.1989-10-30
ABBOTT TESTPACK CHLAMYDIA (K893676)Abbott Laboratories1989-07-25
CHLAMYDIAZYME BLOCKING REAGENT (K892371)Abbott Laboratories1989-06-02
MICROTRAK CHLAMYDIA EIA (K890196)Syva Co.1989-03-22
CHLAMYDIAZYME/COMMANDER INSTRUMENTATION (K885006)Abbott Laboratories1988-12-16
MODIFIED IDEIA CHLAMYDIA TEST (K880799)Boots-Celltech Diagnostics, Inc.1988-12-08
PATHFINDER(TM) CHLAMYDIA EIA DETECT KIT/MODIFIED (K884517)Kallestad Diag, A Div. of Erbamont, Inc.1988-11-30
KODAK SURECELL CHLAMYDIA TEST KIT (K882923)Eastman Kodak Company1988-11-10
FDL ELISA FOR CHLAMYDIA (K883266)Fairleigh Dickinson Laboratories, Inc.1988-10-25
PHARMACIA CHLAMYDIA EIA (K882676)Pharmacia, Inc.1988-08-29
ABBOTT TESTPACK CHLAMYDIA (K880783)Abbott Laboratories1988-07-25
ABBOTT TESTPACK(TM) CHLAMYDIA POSITIVE CONTROL (K882535)Abbott Laboratories1988-07-14
CHLAMYDIAZYME(TM) (K880469)Abbott Laboratories1988-05-23
PATHFINDER(TM) CHLAMYDIA EIA DETECTION KIT (K880824)Kallestad Diag, A Div. of Erbamont, Inc.1988-04-12
CHLAMYSET ANTIBODY EIA (K864457)Orion Corp.1987-09-11
VIVID CHLAMYDIA(TM) (K872148)Seragen Diagnostics, Inc.1987-08-19
MODIFIED (DIRECTIONS FOR USE) FOR IDEIA(TM) TEST (K872056)Boots-Celltech Diagnostics, Inc.1987-06-15
CHLAMYDIAZYME DIAGNOSTIC KIT (K864842)Abbott Laboratories1987-04-29
ORTHO* CHLAMYDIA ANTIGEN ELISA TEST & TRANSPORT (K863490)Ortho Diagnostic Systems, Inc.1986-11-05
CHLAMYDIA TISSUE CULTURE CONFIRMATION TEST (EIA) (K862948)Intercare Diagnostics, Inc.1986-10-17
VISIBLE-CHLAMYDIA(TM) TEST SYSTEM (K862638)Isolab, Inc.1986-08-26
MODIFIED IDEIA CHLAMYDIA TEST (K861966)Boots-Celltech Diagnostics, Inc.1986-08-19
APPLELISA CHLAMYDIA TRACHOMATIS ANTI (K843120)Apple Diagnostic Products1984-09-12
CHLAMYDIAZYME, ENZYME IMMUNOASSAY DETEC (K831962)Abbott Laboratories1983-10-05
CHLAMYDELISA TEST KIT (K821967)M.A. Bioproducts1982-08-03

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