GQS · Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4
Microbiology · 21 CFR 866.3400 · Class 1
Overview
| Product Code | GQS |
|---|---|
| Device Name | Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4 |
| Regulation | 21 CFR 866.3400 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
Identification
Parainfluenza virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to parainfluenza virus in serum. The identification aids in the diagnosis of parainfluenza virus infections and provides epidemiological information on diseases caused by these viruses. Parainfluenza viruses cause a variety of respiratory illnesses ranging from the common cold to pneumonia.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.
Recent Cleared Devices (11 of 11)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K093415 | D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KIT | Diagnostic Hybrids, Inc. | Dec 23, 2009 | SESE |
| K943557 | IMAGEN | Dako Diagnostics , Ltd. | Jan 9, 1995 | SESE |
| K905385 | P.I.V. COMPLEMENT-FIXATION (C.F.) ANTIGEN | Virion (U.S.), Inc. | Mar 21, 1991 | SESE |
| K884194 | PARAINFLUENZA TYPE 1 IFA TEST KIT FOR ANTI. DETECT | Baxter Diagnostics, Inc. | Nov 22, 1988 | SESE |
| K884193 | PARAINFLUENZA TYPE 3 IFA TEST KIT FOR ANTI. DETECT | Baxter Diagnostics, Inc. | Nov 22, 1988 | SESE |
| K871234 | ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 1 | Microscan Div. Baxter Healthcare Corp. | Jun 26, 1987 | SESE |
| K871232 | ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 3 | Microscan Div. Baxter Healthcare Corp. | Jun 26, 1987 | SESE |
| K871228 | ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 2 | Microscan Div. Baxter Healthcare Corp. | Jun 26, 1987 | SESE |
| K843667 | PARAINFLUENZA 3 | Institute Virion , Ltd. | Sep 26, 1985 | SESE |
| K843665 | PARAINFLUENZA 1 | Institute Virion , Ltd. | Sep 26, 1985 | SESE |
| K802935 | PARAINFLUENZA 1,2, & 3 ANTIGENS & CONTR | Orion Diagnostica, Inc. | Dec 31, 1980 | SESE |
Top Applicants
- Microscan Div. Baxter Healthcare Corp. — 3 clearances
- Baxter Diagnostics, Inc. — 2 clearances
- Institute Virion , Ltd. — 2 clearances
- Dako Diagnostics , Ltd. — 1 clearance
- Diagnostic Hybrids, Inc. — 1 clearance
