ReQuest EB VCA M
ReQuest EB VCA M (Q01-480) is a Class I device made by Quest International, Inc., listed in FDA GUDID since 31 Aug 2016 (UDI-DI 00850487007173), registry data as of 22 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00850487007173 | Date31 Aug 2016 | StatusListed |
Official records
- AccessGUDID record 00850487007173
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- ReQuest
- Generic name
- Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
- Model / Ref / Catalog
- EB VCA M, Q01-480
- Primary DI / UDI-DI
- 00850487007173
- FDA product code
- LJN
- GMDN term
- Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
- Device class
- Class I
- Regulation number
- 866.3235
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code LJN (Antibody Igm, If, Epstein-Barr Virus).
- EPSTEIN-BARR VIRUS VCA (IGM) RECOMB IMMUN ANTIBODY by Mrl Diagnostics
- EBV-VCA-IGM IFA TEST SYSTEM by ZEUS SCIENTIFIC, INC.
- BIOPLEX 2200 EBV IGM KIT by Bio-Rad Laboratories
- BION EBV-M (VCA) TEST SYSTEM by Bion Ent., Ltd.
- RESUBMITTED EBV/IGM-CHECK TEST KIT by Diagnostic Technology, Inc.
- IMMUNOWELL VCA IGM TEST by Genbio
- EBV-VCA IGM ELISA by Pharmacia Diagnostics, Inc.
- SERAQUEST EB VAC IGM by Quest Intl., Inc.
- AMIZYME EPSTEIN-BARR VIRUS (EBV) IGM ANTIBODY TEST by Amico Laboratories, Inc.
- MODIFICATION TO SERAQUEST VCA IGM by Quest Intl., Inc.