Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)
FDA product code LJC · 67 cleared devices
Class 1
Microbiology
- Regulation
- 21 CFR 866.3120
- Review panel
- MI
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1982-08-03 – 2004-03-02
LJC
2004-03-02
LJC
2004-01-21
IDEIA PCE CHLAMYDIA
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LJC
2003-11-26
CHLAMYDIA IGG ELISA TEST SYSTEM
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LJC
1998-07-09
MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIA
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LJC
1997-02-24
CHLAMYDIA IGG ELISA TEST SYSTEM
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LJC
1997-02-04
ACCESS CHLAMYDIA ASSAY
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LJC
1996-10-07
VIDAS CHLAMYDIA BLOCKING ASSAY
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LJC
1996-05-30
IMX SELECT CHLAMYDIA
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LJC
1996-01-11
IDEIA(TM) CHLAMYDIA BLOCKING REAGENTS, MODIFICATION
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LJC
1995-10-07
CHLAMYDIA OIA
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LJC
1995-05-19
QUICKVUE(R) CHLAMYDIA TEST
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LJC
1995-05-19
ACCESS(R) CHLAMYDIA EIA AND BLOCKING ASSAY
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LJC
1994-09-20
CHLAMYDIA MICROPLATE EIA, CHLAMYDIA MICROPLAE EIA BLOCKING ASSAY
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LJC
1993-09-30
SYVA MICROTRAK(R) II CHLAMYDIA EIA BLOCK REAGENT
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LJC
1992-10-01
MICRO TRAK XL SYSTEM
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LJC
1992-09-25
MICROTRAK(R) II CHLAMYDIA EIA ASSAY
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LJC
1992-09-25
SYVA MICROTRAK CHLAMYDIA EIA
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LJC
1992-08-11
ORTHO CHLAMYDIA ANTIGEN ELISA TEST
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LJC
1992-06-09
SEROELISA(TM) CHLAMYDIA IGA TEST KIT
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LJC
1992-03-23
SEROLISA CHLAMYDIA IGG TEST KIT
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LJC
1992-03-04
VIDAS CHLAMYDIA ASSAY, MODIFICATION
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LJC
1991-07-22
ANTIGENZ CHLAMYDIA
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LJC
1991-04-29
VIDAS CHLAMYDIA ASSAY VITEK IMMUNDIAG ASSAY SYST
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LJC
1991-03-27
CIBA CORNING MAGIC LITE CHLAMYDIA IMMUNOASSAY
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LJC
1991-03-19
ORTHO* CHLAMYDIA ANTIGEN ELISA TEST/MODIFICATION
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LJC
1991-03-12
SYVA MICROTRAK CHLAMLYDIA EIA, MODIFICATION
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LJC
1991-01-14
CHLAMYDIA SYSTEM SOFTWARE (CSS)
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LJC
1990-12-21
ORTHO CHLAMYDIA ANTIGEN ELISA/ELISA CULT EXTRA BUF
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LJC
1990-10-02
QUIDEL CHLAMYDIA POSITIVE CONTROL
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LJC
1990-09-12
SYVA MICROTRAK EIA ACCESSORY REAGENTS
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LJC
1990-09-05
ADD'L CLAIMED INTENDED USE FOR IDEIA(TM) CHLAMYDIA
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LJC
1990-07-31
CIBA CORNING MAGIC LITE CHLAMYDIA IMMUNOASSAY
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LJC
1990-07-27
QUIDEL CHLAMYDIA TEST
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LJC
1990-07-26
PATHFINDER(TM) CHLAMYDIA MICROPLATE KIT
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LJC
1990-06-20
KODAK SURECELL(TM) CHLAMYDIA CONTROL FLUID SET
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LJC
1990-05-15
VISUWELL(R) CHLAMYDIA
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LJC
1990-05-03
CHLAMYDIAZYME DIAGNOSTIC KIT
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LJC
1990-03-13
ORGENICS IMMUNOCOMB(TM) CHLAMYDIA TRACHOMATIS IGG
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LJC
1990-03-08
ADD'L USES FOR THE KODAK SURECELL CHLAMYDIA KIT
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LJC
1990-01-29
MODIFIED ELISA FOR CHLAMYDIA
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LJC
1990-01-29
CLEARVIEW CHLAMYDIA
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LJC
1990-01-02
KODAK SURECELL CHLAMYDIA TEST KIT (ADD'L USES)
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LJC
1989-10-30
CIBA CORNING MAGIC LITE CHLAMYDIA IMMUNOASSAY
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LJC
1989-07-25
ABBOTT TESTPACK CHLAMYDIA
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LJC
1989-06-02
CHLAMYDIAZYME BLOCKING REAGENT
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LJC
1989-03-22
MICROTRAK CHLAMYDIA EIA
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LJC
1988-12-16
CHLAMYDIAZYME/COMMANDER INSTRUMENTATION
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LJC
1988-12-08
MODIFIED IDEIA CHLAMYDIA TEST
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LJC
1988-11-30
PATHFINDER(TM) CHLAMYDIA EIA DETECT KIT/MODIFIED
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LJC
1988-11-10
KODAK SURECELL CHLAMYDIA TEST KIT
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LJC
1988-10-25
FDL ELISA FOR CHLAMYDIA
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LJC
1988-08-29
PHARMACIA CHLAMYDIA EIA
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LJC
1988-07-25
ABBOTT TESTPACK CHLAMYDIA
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LJC
1988-07-14
ABBOTT TESTPACK(TM) CHLAMYDIA POSITIVE CONTROL
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LJC
1988-05-23
CHLAMYDIAZYME(TM)
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LJC
1988-04-12
PATHFINDER(TM) CHLAMYDIA EIA DETECTION KIT
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LJC
1987-09-11
CHLAMYSET ANTIBODY EIA
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LJC
1987-08-19
VIVID CHLAMYDIA(TM)
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LJC
1987-06-15
MODIFIED (DIRECTIONS FOR USE) FOR IDEIA(TM) TEST
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LJC
1987-04-29
CHLAMYDIAZYME DIAGNOSTIC KIT
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LJC
1986-11-05
ORTHO* CHLAMYDIA ANTIGEN ELISA TEST & TRANSPORT
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LJC
1986-10-17
CHLAMYDIA TISSUE CULTURE CONFIRMATION TEST (EIA)
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LJC
1986-08-26
VISIBLE-CHLAMYDIA(TM) TEST SYSTEM
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LJC
1986-08-19
MODIFIED IDEIA CHLAMYDIA TEST
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LJC
1984-09-12
APPLELISA CHLAMYDIA TRACHOMATIS ANTI
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LJC
1983-10-05
CHLAMYDIAZYME, ENZYME IMMUNOASSAY DETEC
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LJC
1982-08-03
CHLAMYDELISA TEST KIT
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