Antisera, Cf, Parainfluenza Virus 1-4
The Antisera, CF, Parainfluenza Virus 1-4 is a complement fixation antiserum used in laboratory testing to detect and differentiate parainfluenza virus types 1 through 4 through serological methods. It is classified as FDA Class 1, subject to general controls only and exempt from premarket notification requirements. The product code is GQT, 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
- GQT
- 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 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K872697 | PARAINFLUENZA-I-CF ANTIGEN AND CONTROL ANTIGEN | Sep 18, 1987 | Substantially Equivalent | Sita, Inc. |
| K872696 | PARAINFLUENZA-3-CF ANTIGEN AND CONTROL ANTIGEN | Sep 18, 1987 | Substantially Equivalent | Sita, Inc. |
| K872695 | PARAINFLUENZA-2-CF ANTIGEN AND CONTROL ANTIGEN | Sep 18, 1987 | Substantially Equivalent | Sita, Inc. |
| K780008 | GOAT ANTI-INFLUENZA ANTISERA | Jan 20, 1978 | Substantially Equivalent | Northeast Biomedical Labs., Inc. |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.