Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4
The Antigens, CF (Including CF Control), Parainfluenza Virus 1-4 is a set of complement fixation antigens with controls used in serological laboratory assays to detect antibodies to parainfluenza viruses 1 through 4. It is an FDA Class 1 device, meaning it poses the lowest level of risk and requires only general controls, with no premarket submission. The product code is GQS, regulated under 21 CFR 866.3400 in the Microbiology specialty. No special flags apply to this device.
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Basic Information
- Product Code
- GQS
- Device Class
- FDA class 1
- Regulation Number
- 866.3400
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 11 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K093415 | D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KIT | Dec 23, 2009 | Substantially Equivalent | Diagnostic Hybrids, Inc. |
| K943557 | IMAGEN | Jan 09, 1995 | Substantially Equivalent | Dako Diagnostics , Ltd. |
| K905385 | P.I.V. COMPLEMENT-FIXATION (C.F.) ANTIGEN | Mar 21, 1991 | Substantially Equivalent | Virion (U.S.), Inc. |
| K884194 | PARAINFLUENZA TYPE 1 IFA TEST KIT FOR ANTI. DETECT | Nov 22, 1988 | Substantially Equivalent | Baxter Diagnostics, Inc. |
| K884193 | PARAINFLUENZA TYPE 3 IFA TEST KIT FOR ANTI. DETECT | Nov 22, 1988 | Substantially Equivalent | Baxter Diagnostics, Inc. |
| K871234 | ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 1 | Jun 26, 1987 | Substantially Equivalent | Microscan Div. Baxter Healthcare Corp. |
| K871232 | ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 3 | Jun 26, 1987 | Substantially Equivalent | Microscan Div. Baxter Healthcare Corp. |
| K871228 | ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 2 | Jun 26, 1987 | Substantially Equivalent | Microscan Div. Baxter Healthcare Corp. |
| K843667 | PARAINFLUENZA 3 | Sep 26, 1985 | Substantially Equivalent | Institute Virion , Ltd. |
| K843665 | PARAINFLUENZA 1 | Sep 26, 1985 | Substantially Equivalent | Institute Virion , Ltd. |
| K802935 | PARAINFLUENZA 1,2, & 3 ANTIGENS & CONTR | Dec 31, 1980 | Substantially Equivalent | Orion Diagnostica, Inc. |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.