Identity
- Trade Name
- DIASTAT anti-B2-Glycoprotein-1 IgM FDA UDI
- Generic Name
- Anticardiolipin-B2-glycoprotein I complex antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Model / Reference
- FBGP100 FDA UDI
Identifiers
- Catalog Number
- FBGP100 FDA UDI
- Primary DI / UDI-DI
- 07340058410158 FDA UDI
- FDA Product Code
- MSV FDA UDI
- GMDN Term
- Anticardiolipin-B2-glycoprotein I complex antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5660 FDA UDI
- 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)
DIASTAT anti-B2-Glycoprotein-1 IgM by Euro-Diagnostica AB — Class II — 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
- REAADS Anti-Beta 2 Glycoprotein I IgA Semi-Quantitative Test Kit (96 Well) — CORGENIX MEDICAL CORPORATION · Class II
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 | Class II | Pending data |
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Manufacturer
- Manufacturer
- Euro-Diagnostica AB
Sources (1)
- FDA UDI bede1a7d-c0a9-437d-a96f-819224bbb1d2 33 fields · synced Jun 8, 2026