GQX — Antiserum, Cf, Varicella-Zoster Class II
FDA product code GQX covers "Antiserum, Cf, Varicella-Zoster", a Class II medical device regulated under 21 CFR 866.3900. Submissions are reviewed by the Microbiology panel. At least 11 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GQX
- Device Class
- Class II
- Regulation Number
- 866.3900
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K951799 | light diagnostics | VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAY | March 20, 1996 |
| K911301 | gull laboratories | VZV IGM TEST | July 17, 1991 |
| K883427 | electro-nucleonics | VIRGO(R) VZV-IGG ELISA | March 10, 1989 |
| K875358 | gull laboratories | VZV TEST | March 31, 1988 |
| K863317 | behring diagnostics | ENZYGNOST ANTI-VZV IGG TEST | April 22, 1987 |
| K853540 | idt, a division of whittaker m.a. bioproducts | FIAX TEST KIT FOR VARICELLA ANTIBODY SEROLOGY | February 4, 1986 |
| K852930 | microbix biosystems | VARICELLA-ZOSTER-COMPLE FIX ANTIGEN AND NEG CONTRO | November 12, 1985 |
| K842096 | great lakes bioscience | GLB VARICELLA-ZOSTER VIRUS FLUORESCENT | January 7, 1985 |
| K841526 | ortho diagnostic systems | ORTHO VARICELLA-ZOSTER VIRUS IDENT. | June 25, 1984 |
| K770810 | flow laboratories | VARICELLA-ZOSTER FA LABELED PRESERUM | May 20, 1977 |
| K770806 | flow laboratories | VARICELLA-ZOSTER FA LABELLED (8-321 RF) | May 20, 1977 |