Product Code: LKT FDA class 1 21 CFR 866.3480

Respiratory Syncytial Virus, Antigen, Antibody, Ifa

Microbiology

Respiratory Syncytial Virus, Antigen, Antibody, IFA is an indirect fluorescent antibody (IFA) test system used to detect antigens or antibodies related to respiratory syncytial virus (RSV), which is a leading cause of lower respiratory tract infections in infants, the elderly, and immunocompromised individuals. This device is classified as FDA Class 1, the lowest risk category, requiring only general controls. The product code is LKT, regulated under 21 CFR 866.3480, within the Microbiology medical specialty. No special flags apply to this device.

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FEI Numbers

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Basic Information

Product Code: LKT
Device Class: FDA class 1
Regulation Number: 866.3480
Medical Specialty: Microbiology
Review Panel: MI
Submission Type: 4

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 23 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K081928	D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT	Dec 23, 2008	Substantially Equivalent	Diagnostic Hybrids, Inc.
K983336	PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1	Mar 18, 1999	Substantially Equivalent	Diagnostic Products Corp.
K943317	PATHODX RESPIRATORY SYNCYTIAL VIRUS (RSV)	Dec 19, 1994	Substantially Equivalent	Diagnostic Products Corp.
K942173	RSV ANTIGEN TEST	Jun 30, 1994	Substantially Equivalent	Neogenex
K912842	RSV-MAB TEST	Dec 09, 1991	Substantially Equivalent	Gull Laboratories, Inc.
K912838	BARTELS RESPIRATORY SYNCYTIAL VIRUS ENZYME IMMUNO	Sep 27, 1991	Substantially Equivalent	Baxter Diagnostics, Inc.
K912371	BIOMERIEUX RSV DIRECT IF KIT	Sep 23, 1991	Substantially Equivalent	Vitek Systems, Inc.
K894623	RESPIRATORY SYNCYTIAL VIRUS	Oct 16, 1989	Substantially Equivalent	Bion Ent., Ltd.
K884192	RSV IFA TEST KIT FOR DIRECT ANTIGEN DETECTION	Nov 22, 1988	Substantially Equivalent	Baxter Diagnostics, Inc.
K882687	ANTI-RESPIRATORY SYNCYTIAL VIRUS ANTIBODY TEST	Aug 30, 1988	Substantially Equivalent	Gull Laboratories, Inc.
K873564	GENETIC SYSTEMS RSV REAGENT CONTROL SLIDES	Nov 20, 1987	Substantially Equivalent	Genetic Systems Corp.
K872701	RESPIRATORY SYNCYTIAL VIRUS CF ANTIGEN & CONTROL	Sep 18, 1987	Substantially Equivalent	Sita, Inc.
K872082	RESPIRATORY SYNCYTIAL VIRUS CONTROL SLIDE	Jul 31, 1987	Substantially Equivalent	Medical Diagnostic Technologies, Inc.
K870176	GENETIC SYSTEMS RSV IMMUNOFLUORESCENCE TEST KIT	Jul 16, 1987	Substantially Equivalent	Genetic Systems Corp.
K871230	ANTIBODY ASSAY FOR DETEC. OF RESP. SYNCYTIAL VIRUS	Jun 26, 1987	Substantially Equivalent	Microscan Div. Baxter Healthcare Corp.
K862321	CELLMATICS RSV DETECTION SYSTEM	Aug 21, 1986	Substantially Equivalent	Difco Laboratories, Inc.
K861379	MONABRITE RESPIR SYNCYTIAL VIRUS(RSV) TEST KIT	Jul 16, 1986	Substantially Equivalent	Serono Diagnostics, Inc.
K852472	ABBOTT RSV EIA	Sep 17, 1985	Substantially Equivalent	Abbott Laboratories
K852185	RESPIRATORY SYNCYTIAL VIRUS DIRECT FLUORESCENT ANT	Aug 19, 1985	Substantially Equivalent	Bartels Immunodiagnostic Supplies, Inc.
K844721	INNOFLUOR PRIMIDONE	Jan 08, 1985	Substantially Equivalent	Innotron Diagnostics
K842047	ORTHO* RSV ANTIGEN ELISA TEST SYS	Oct 05, 1984	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K841527	ORTHO RESPIRATORY SYNCYTIAL VIRUS-	Aug 12, 1984	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K831924	ANTIBODY TO RESPIRATORY SYNCYTIAL VIRUS	Aug 11, 1983	Substantially Equivalent	Electro-Nucleonics Laboratories, Inc.