GQX — Antiserum, Cf, Varicella-Zoster Class II
FDA Device Classification
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 |
| K770806 | flow laboratories | VARICELLA-ZOSTER FA LABELLED (8-321 RF) | May 20, 1977 |
| K770810 | flow laboratories | VARICELLA-ZOSTER FA LABELED PRESERUM | May 20, 1977 |