Is-Vzu Igg Test System
510(k) K981867
Is-Vzu Igg Test System is a Class II device made by Diamedix Corp., cleared under FDA 510(k) K981867 on 28 Sep 1998, active as of 10 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK981867 | Date28 Sep 1998 | StatusActive |
Official records
- FDA 510(k) database K981867
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LFY
- Device class
- Class II
- Regulation
- 21 CFR Part 866.3900
- Advisory committee
- Microbiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K981867
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Diamedix 720-400 | 720-400 | 00817273020228 | On the market | |
| Gold Standard Diagnostics Is-VZV IgG ELISA Test Kit 720-380 | 720-380 / 720-380 | B3507203800 | On the market |
Similar devices
Other devices filed under FDA product code LFY (Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster).
- VZV BIO-ENZABEAD SCREEN KIT by Bionetic Laboratory Products
- VARICELLA ZOSTER IGG CLIN-ELISA TEST KIT by Clinical Sciences, Inc.
- VARICELISA TEST KIT by M.A. Bioproducts
- BioPlex 2200 6652450 by Bio-Rad Laboratories
- BioPlex 2200 6632400 by Bio-Rad Laboratories
- ZEUS SCIENTIFIC, INC VZV IGM ELISA TEST SYSTEM by ZEUS SCIENTIFIC, INC.
- DIASORIN LIAISON VZV IGG by Diasorin Inc.
- LIAISON VZV IgG HT, LIAISON Control VZV IgG HT by Diasorin Inc.
- Aptus Automated Application of the VZV IgG ELISA Test System by ZEUS SCIENTIFIC, INC.
- SERAQUEST VZV IGG by Quest Intl., Inc.