Product Code: LIN FDA class 2 21 CFR 866.3175

Antisera, Conjugated Fluorescent, Cytomegalovirus

Microbiology

Conjugated fluorescent antisera for cytomegalovirus (CMV) are microbiological diagnostic reagents consisting of antibodies labeled with fluorescent dyes used to detect CMV in patient specimens via fluorescence microscopy, supporting the direct diagnosis of CMV infection. The device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. It carries product code LIN and is regulated under 21 CFR 866.3175 within the Microbiology specialty. This device is eligible for third-party review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

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Basic Information

Product Code: LIN
Device Class: FDA class 2
Regulation Number: 866.3175
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 17 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K081164	D3 DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATION KIT	Jun 13, 2008	Substantially Equivalent	Diagnostic Hybrids, Inc.
K983762	NUCLISENS CMV PP67	Sep 15, 1999	Substantially Equivalent	Organon Teknika Corp.
K991650	CMV BRITE TURBO KIT	Jul 12, 1999	Substantially Equivalent	Biotest Diagnostics Corp.
K951821	CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAY	Jun 07, 1996	Substantially Equivalent	Light Diagnostics
K951550	CMV BRITE ANTIGENEMIA TEST KIT	Jan 30, 1996	Substantially Equivalent	Biotest Diagnostics Corp.
K934798	PATHODX CYTOMEGALOVIRUS	Mar 25, 1994	Substantially Equivalent	Diagnostic Products Corp.
K921616	CMV-VUE(TM) CMV ANTIGEN DETECTION KIT	Aug 11, 1992	Substantially Equivalent for Some Indications	Incstar Corp.
K912592	CMV-EA MAB TEST	Dec 04, 1991	Substantially Equivalent	Gull Laboratories, Inc.
K905257	OPUS CMV TEST SYSTEM	Apr 17, 1991	Substantially Equivalent	Pb Diagnostic Systems, Inc.
K904036	BARTELS CYTOMEGALOVIRUS IMMED. EARLY ANTIGEN	Oct 16, 1990	Substantially Equivalent	Baxter Healthcare Corp
K894002	CYTOMEGALOVIRUS FLUORESCENT MONOCLONAL ANTIBODY	Aug 10, 1989	Substantially Equivalent	Baxter Healthcare Corp
K893468	CMV IGG ANTIBODY TEST (INDIRECT FLUORESCENT TEST)	Jul 14, 1989	Substantially Equivalent	Immuno Concepts, Inc.
K893467	CMV IGG ANTIBODY TEST (INDIRECT ENZYME TEST)	Jul 14, 1989	Substantially Equivalent	Immuno Concepts, Inc.
K860279	CYTOMEGALOVIRUS DIRECT FLUORESCENT ANTIBODY KIT	May 13, 1986	Substantially Equivalent	Bartels Immunodiagnostic Supplies, Inc.
K843138	CMV TEST	Jan 29, 1985	Substantially Equivalent	Microbiological Research Corp.
K822606	CYTOMEGALOVIRUS ANTOBODY IGG	Nov 01, 1982	Substantially Equivalent	Immulok, Inc.
K820895	CYLOMEGALOVIRUS DIRECT FLUORESCENT ANTI	May 03, 1982	Substantially Equivalent	Bartels Immunodiagnostic Supplies, Inc.