Product Code: LJP FDA class 1 21 CFR 866.3120

Antiserum, Fluorescent, Chlamydia Trachomatis

Microbiology

Antiserum, Fluorescent, Chlamydia Trachomatis is a fluorescent-labeled antiserum used in laboratory assays to identify Chlamydia trachomatis, the bacterium responsible for one of the most common sexually transmitted infections and a leading cause of preventable infectious blindness. This device is classified as FDA Class 1, the lowest risk category, requiring only general controls. The product code is LJP, regulated under 21 CFR 866.3120, within the Microbiology medical specialty. This device is eligible for third-party 510(k) review.

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FEI Numbers

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Basic Information

Product Code: LJP
Device Class: FDA class 1
Regulation Number: 866.3120
Medical Specialty: Microbiology
Review Panel: MI
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 35 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K063675	DIAGNOSTIC HYBRIDS' D3 DFA CHLAMYDIAE CULTURE CONFIRMATION KIT	Sep 24, 2007	Substantially Equivalent	Diagnostic Hybrids, Inc.
K941714	CHLAMYDIA TRACHOMATIS ANTIGEN TEST	Jul 18, 1994	Substantially Equivalent	Neogenex
K901243	CHLAMYDIA-CEL IMMUNOFLUORENSCENCE (IF) TEST	May 21, 1990	Substantially Equivalent	Cel Labs Pty, Ltd.
K900870	PATHODX CHLAMYDIA TRACHOMATIS DIRECT SPECIMEN TEST	Apr 16, 1990	Substantially Equivalent	Diagnostic Products Corp.
K895839	PATHODX CHLAMYDIA CULTURE CONFIRMATION PKCC1	Feb 01, 1990	Substantially Equivalent	Diagnostic Products Corp.
K883352	FLUORESCEIN CONJUGATED ANTI-CHLAMYDIA MONO ANTI	Oct 06, 1988	Substantially Equivalent	Whittaker Bioproducts, Inc.
K881500	ORTHO* CHLAMYDIA DIRECT DETECTION (FA) TEST	Apr 27, 1988	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K880031	PATHFINDER(TM) DIRECT DETECTION SYS C. TRACHOMATIS	Mar 17, 1988	Substantially Equivalent	Kallestad Diag, A Div. of Erbamont, Inc.
K872744	MODIFIED CHLAMYSET ANTIGEN	Sep 22, 1987	Substantially Equivalent	Orion Corp.
K872903	MICROTRAK CHLAMYDIA TRACHO. TEST - METHANOL FIXAT.	Aug 06, 1987	Substantially Equivalent	Syva Co.
K870946	MONABRITE CHLAMYDIA TRACHOMATIS DIR. SPECIMEN TEST	Apr 29, 1987	Substantially Equivalent	Serono Diagnostics, Inc.
K864128	CHLAMYDIA-CHECK(TM) DIRECT & CULTURE CONFIR. KIT	Apr 29, 1987	Substantially Equivalent	Diagnostic Technology, Inc.
K871278	MODIFIED CHLAMYDIA DIRECT SPECIMEN TEST KIT	Apr 08, 1987	Substantially Equivalent	California Integrated Diagnostics, Inc.
K864662	CHLAMYDIAE FLUOR. AB TEST FOR DETECTION IN SMEARS	Mar 25, 1987	Substantially Equivalent	American Micro Scan
K864539	MODIFIED IMAGEN(TM) CHLAMYDIA TEST	Mar 12, 1987	Substantially Equivalent	Boots-Celltech Diagnostics, Inc.
K864888	MICROTRAK CHLAMYDIA TRACHOMATIS DIRECT SPECI. TEST	Feb 25, 1987	Substantially Equivalent	Syva Co.
K864663	PATHFINDER CHLAMYDIA CULTURE CONFIRMATION SYSTEM	Feb 02, 1987	Substantially Equivalent	Kallestad Diag, A Div. of Erbamont, Inc.
K864389	CHLAMYDIAE FLOURESCENT MONOCLONAL ANTIBODY TEST	Dec 04, 1986	Substantially Equivalent	American Micro Scan
K863681	PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEM	Dec 03, 1986	Substantially Equivalent	Kallestad Laboratories, Inc.
K862354	MONOFLUOR CHLAMYDIA TRACHOMATIS DIR SPEC TEST KIT	Sep 29, 1986	Substantially Equivalent	Synbiotics Corp.
K862320	DIFCO CHLAMYDIA DIRECT DETECTION SYSTEM	Aug 19, 1986	Substantially Equivalent	Difco Laboratories, Inc.
K853401	CHLAMYSET ANTIGEN	Apr 28, 1986	Substantially Equivalent	Orion Corp.
K860179	CELLMATICS CHLAMYDIA MONOCLONAL DFA REAGENT	Mar 10, 1986	Substantially Equivalent	Difco Laboratories, Inc.
K853738	ORTHO CHLAMYDIA DIRECT DETECTION (FA) TEST	Dec 06, 1985	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K852779	MICROTRAK CHLAMYDIA TRACHOMATIS DIR SPECIMEN TEST	Sep 16, 1985	Substantially Equivalent	Syva Co.
K851033	SYNCORTECH CHLAMYDIA DIRECT SPECIMAN KIT	Jun 21, 1985	Substantially Equivalent	Syncor Intl. Corp.
K850158	CHLAMYDIA FLUORO-KIT 1680	Mar 21, 1985	Substantially Equivalent	Clinical Sciences, Inc.
K844582	SYNCOR TECH CHLAMYDIA TISSUE CULTURE TEST	Jan 16, 1985	Substantially Equivalent	Syncor Intl. Corp.
K842658	ANTI-CHLAMYDIA TRACHOMATIS KIT	Oct 01, 1984	Substantially Equivalent	Amico Lab, Inc.
K842525	AMIZYME-C TRACHOMATIS TEST KIT	Oct 01, 1984	Substantially Equivalent	Amico Lab, Inc.
K842623	MICROTRAK CHLAMYDIA TRACHOMATIS DIRECT	Aug 02, 1984	Substantially Equivalent	Syva Co.
K834242	ADP IFA TEST FOR CHLAMYDIAE TRACHOMATIS	Mar 02, 1984	Substantially Equivalent	Apple Diagnostic Products
K832078	MICRO TRAK CHLAMYDIA TRAC CONTROL SLID	Sep 29, 1983	Substantially Equivalent	Syva Co.
K832077	MICRO TRAK CHLAMYDIA TRACHOMATIS DIRECT	Sep 29, 1983	Substantially Equivalent	Syva Co.
K823010	MICRO TRAK CHLAMYDIA TRACHOMATIS CULT	Dec 15, 1982	Substantially Equivalent	Syva Co.