Antiserum, Fluorescent, Chlamydia Trachomatis

FDA product code LJP · 35 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: 1982-12-15 – 2007-09-24

LJP 2007-09-24

DIAGNOSTIC HYBRIDS' D3 DFA CHLAMYDIAE CULTURE CONFIRMATION KIT

Applicant Diagnostic Hybrids, Inc.

K number K063675

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LJP 1994-07-18

CHLAMYDIA TRACHOMATIS ANTIGEN TEST

Applicant Neogenex

K number K941714

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LJP 1990-05-21

CHLAMYDIA-CEL IMMUNOFLUORENSCENCE (IF) TEST

Applicant Cel Labs Pty, Ltd.

K number K901243

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LJP 1990-04-16

PATHODX CHLAMYDIA TRACHOMATIS DIRECT SPECIMEN TEST

Applicant Diagnostic Products Corp.

K number K900870

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LJP 1990-02-01

PATHODX CHLAMYDIA CULTURE CONFIRMATION PKCC1

Applicant Diagnostic Products Corp.

K number K895839

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LJP 1988-10-06

FLUORESCEIN CONJUGATED ANTI-CHLAMYDIA MONO ANTI

Applicant Whittaker Bioproducts, Inc.

K number K883352

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LJP 1988-04-27

ORTHO* CHLAMYDIA DIRECT DETECTION (FA) TEST

Applicant Ortho Diagnostic Systems, Inc.

K number K881500

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LJP 1988-03-17

PATHFINDER(TM) DIRECT DETECTION SYS C. TRACHOMATIS

Applicant Kallestad Diag, A Div. of Erbamont, Inc.

K number K880031

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LJP 1987-09-22

MODIFIED CHLAMYSET ANTIGEN

Applicant Orion Corp.

K number K872744

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LJP 1987-08-06

MICROTRAK CHLAMYDIA TRACHO. TEST - METHANOL FIXAT.

Applicant Syva Co.

K number K872903

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LJP 1987-04-29

MONABRITE CHLAMYDIA TRACHOMATIS DIR. SPECIMEN TEST

Applicant Serono Diagnostics, Inc.

K number K870946

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LJP 1987-04-29

CHLAMYDIA-CHECK(TM) DIRECT & CULTURE CONFIR. KIT

Applicant Diagnostic Technology, Inc.

K number K864128

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LJP 1987-04-08

MODIFIED CHLAMYDIA DIRECT SPECIMEN TEST KIT

Applicant California Integrated Diagnostics, Inc.

K number K871278

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LJP 1987-03-25

CHLAMYDIAE FLUOR. AB TEST FOR DETECTION IN SMEARS

Applicant American Micro Scan

K number K864662

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LJP 1987-03-12

MODIFIED IMAGEN(TM) CHLAMYDIA TEST

Applicant Boots-Celltech Diagnostics, Inc.

K number K864539

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LJP 1987-02-25

MICROTRAK CHLAMYDIA TRACHOMATIS DIRECT SPECI. TEST

Applicant Syva Co.

K number K864888

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LJP 1987-02-02

PATHFINDER CHLAMYDIA CULTURE CONFIRMATION SYSTEM

Applicant Kallestad Diag, A Div. of Erbamont, Inc.

K number K864663

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LJP 1986-12-04

CHLAMYDIAE FLOURESCENT MONOCLONAL ANTIBODY TEST

Applicant American Micro Scan

K number K864389

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LJP 1986-12-03

PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEM

Applicant Kallestad Laboratories, Inc.

K number K863681

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LJP 1986-09-29

MONOFLUOR CHLAMYDIA TRACHOMATIS DIR SPEC TEST KIT

Applicant Synbiotics Corp.

K number K862354

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LJP 1986-08-19

DIFCO CHLAMYDIA DIRECT DETECTION SYSTEM

Applicant Difco Laboratories, Inc.

K number K862320

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LJP 1986-04-28

CHLAMYSET ANTIGEN

Applicant Orion Corp.

K number K853401

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LJP 1986-03-10

CELLMATICS CHLAMYDIA MONOCLONAL DFA REAGENT

Applicant Difco Laboratories, Inc.

K number K860179

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LJP 1985-12-06

ORTHO CHLAMYDIA DIRECT DETECTION (FA) TEST

Applicant Ortho Diagnostic Systems, Inc.

K number K853738

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LJP 1985-09-16

MICROTRAK CHLAMYDIA TRACHOMATIS DIR SPECIMEN TEST

Applicant Syva Co.

K number K852779

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LJP 1985-06-21

SYNCORTECH CHLAMYDIA DIRECT SPECIMAN KIT

Applicant Syncor Intl. Corp.

K number K851033

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LJP 1985-03-21

CHLAMYDIA FLUORO-KIT 1680

Applicant Clinical Sciences, Inc.

K number K850158

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LJP 1985-01-16

SYNCOR TECH CHLAMYDIA TISSUE CULTURE TEST

Applicant Syncor Intl. Corp.

K number K844582

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LJP 1984-10-01

ANTI-CHLAMYDIA TRACHOMATIS KIT

Applicant Amico Lab, Inc.

K number K842658

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LJP 1984-10-01

AMIZYME-C TRACHOMATIS TEST KIT

Applicant Amico Lab, Inc.

K number K842525

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LJP 1984-08-02

MICROTRAK CHLAMYDIA TRACHOMATIS DIRECT

Applicant Syva Co.

K number K842623

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LJP 1984-03-02

ADP IFA TEST FOR CHLAMYDIAE TRACHOMATIS

Applicant Apple Diagnostic Products

K number K834242

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LJP 1983-09-29

MICRO TRAK CHLAMYDIA TRAC CONTROL SLID

Applicant Syva Co.

K number K832078

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LJP 1983-09-29

MICRO TRAK CHLAMYDIA TRACHOMATIS DIRECT

Applicant Syva Co.

K number K832077

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LJP 1982-12-15

MICRO TRAK CHLAMYDIA TRACHOMATIS CULT

Applicant Syva Co.

K number K823010

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