VIRGO(R) VZV-IGG ELISA
FDA 510(k) clearance K883427 · decided 1989-03-10
Clearance details
- K-number
- K883427
- Device name
- VIRGO(R) VZV-IGG ELISA
- Applicant
- Electro-Nucleonics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-08-15
- Decision date
- 1989-03-10
- Days to decision
- 207 days
- Clearance type
- Traditional
- Product code
- GQX
- Device class
- 2
- Regulation number
- 866.3900
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Columbia, MD, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAY (K951799) | Light Diagnostics | 1996-03-20 |
| VZV IGM TEST (K911301) | Gull Laboratories, Inc. | 1991-07-17 |
| VZV TEST (K875358) | Gull Laboratories, Inc. | 1988-03-31 |
| ENZYGNOST ANTI-VZV IGG TEST (K863317) | Behring Diagnostics, Inc. | 1987-04-22 |
| FIAX TEST KIT FOR VARICELLA ANTIBODY SEROLOGY (K853540) | Idt, A Division of Whittaker M.A. Bioproducts | 1986-02-04 |
| VARICELLA-ZOSTER-COMPLE FIX ANTIGEN AND NEG CONTRO (K852930) | Microbix Biosystems, Inc. | 1985-11-12 |
| GLB VARICELLA-ZOSTER VIRUS FLUORESCENT (K842096) | Great Lakes Bioscience | 1985-01-07 |
| ORTHO VARICELLA-ZOSTER VIRUS IDENT. (K841526) | Ortho Diagnostic Systems, Inc. | 1984-06-25 |
| VARICELLA-ZOSTER FA LABELLED (8-321 RF) (K770806) | Flow Laboratories, Inc. | 1977-05-20 |
| VARICELLA-ZOSTER FA LABELED PRESERUM (K770810) | Flow Laboratories, Inc. | 1977-05-20 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests; product code: 2325601: 48 recall (Z-2445-2012) | Clark Laboratories, Inc. (dba,Trinity Biotech USA) | 2012-09-24 |