Identity
- Trade Name
- EL-B2GPI Scr FDA UDI
- Generic Name
- Anticardiolipin-B2-glycoprotein I complex antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- ANTI-BETA 2 GLYCOPROTEIN I ANTIBODY SCREENING ELISA TEST KIT, 96 TESTS FDA UDI
- Model / Reference
- 402-401 FDA UDI
- Description
- ANTI-BETA 2 GLYCOPROTEIN I ANTIBODY SCREENING ELISA TEST KIT, 96 TESTS FDA UDI
Identifiers
- Catalog Number
- 402-401 FDA UDI
- Primary DI / UDI-DI
- 00854473003286 FDA UDI
- 510(k) Number
- K092757 FDA UDI
- GMDN Term
- Anticardiolipin-B2-glycoprotein I complex antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Anticardiolipin-B2-glycoprotein I complex antibody IVD, kit, enzyme immunoassay (EIA)
EL-B2GPI Scr by Theratest Laboratories, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Anticardiolipin-B2-glycoprotein I complex antibody IVD, kit, enzyme immunoassay (EIA).
- AESKULISA® ß2-Glyco-A — Aesku.Diagnostics GmbH & Co. KG · Class II
- Corgenix Anti-Beta 2 Glycoprotein I IgA Semi-Quantitative Test Kit (192 Well) — CORGENIX MEDICAL CORPORATION · Class II
- AESKULISA® ß2-Glyco-Check — Aesku.Diagnostics GmbH & Co. KG · Class II
- AESKULISA® ß2-Glyco-GM — Aesku.Diagnostics GmbH & Co. KG · Class II
- REAADS Anti-Beta 2 Glycoprotein I IgM Semi-Quantitative Test Kit (96 Well) — CORGENIX MEDICAL CORPORATION · Class II
- Corgenix Anti-Beta 2 Glycoprotein I IgG Semi-Quantitative Test Kit (192 Well) — CORGENIX MEDICAL CORPORATION · Class II
- AESKULISA® ß2-Glyco-Check — Aesku.Diagnostics GmbH & Co. KG · Class II
- DIASTAT anti-B2-Glycoprotein-1 IgM — Euro-Diagnostica AB · Class II
Cleared under the same submission
K092757 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Theratest Laboratories, Inc.
Sources (1)
- FDA UDI 75664c74-87bf-4baa-a25e-73aa1b25b525 36 fields · synced May 30, 2026