ReQuest TOXO M
ReQuest TOXO M (Q01-130) is a Class II device made by Quest International, Inc., listed in FDA GUDID since 31 Aug 2016 (UDI-DI 00850487007029), 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 | Number00850487007029 | Date31 Aug 2016 | StatusListed |
Official records
- AccessGUDID record 00850487007029
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- ReQuest
- Generic name
- Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
- Model / Ref / Catalog
- TOXO M, Q01-130
- Primary DI / UDI-DI
- 00850487007029
- FDA product code
- LGD
- GMDN term
- Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
- Device class
- Class II
- Regulation number
- 866.3780
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code LGD (Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii).
- ADVIA Centaur® Toxo M 10310320 120153 by Siemens Healthcare Diagnostics Inc.
- TOXOPLASMA IGG CLIN-ELISA TEST KIT CAT. NO. 4560 by Clinical Sciences, Inc.
- IMX TOXO IGG by Abbott Laboratories
- TOXO IGG ELISA TEST by Gull Laboratories, Inc.
- ORTHO* TOXOPLASMA-M ANTIBODY ELISA TEST by Ortho Diagnostic Systems, Inc.
- TOXOPLASMA IGM ASSAY FOR THE BAYER IMMUNO1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) by Bayer Corp.
- LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG II by Diasorin Inc.
- SERODOT TOXOPLASMA IGG TEST KIT by Disease Detection International, Inc.
- TOXO-G EIA DIAGNOSTIC KIT by Abbott Laboratories
- INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAY by Incstar Corp.