Identity
- Trade Name
- AESKULISA® ß2-Glyco-A FDA UDI
- Generic Name
- Anticardiolipin-B2-glycoprotein I complex antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- AESKULISA β2 Glyco-A is a solid phase enzyme immunoassay employing native β2 glycoprotein I highly purified from human plasma for the quantitative and qualitative detection of IgA antibodies against β2 glycoprotein I in human serum. Anti-β2 glycoprotein I antibodies recognize specific epitopes on human β2 glycoprotein I which are expressed only when β2 glycoprotein I interacts with lipid membranes or when absorbed to other surfaces (e.g. microtiter plate). The assay is an aid in the diagnosis and risk of primary and secondary antiphospholipid syndrome. 30'+30'+30' automation incubation. FDA UDI
- Model / Reference
- 30-7205US FDA UDI
- Description
- AESKULISA β2 Glyco-A is a solid phase enzyme immunoassay employing native β2 glycoprotein I highly purified from human plasma for the quantitative and qualitative detection of IgA antibodies against β2 glycoprotein I in human serum. Anti-β2 glycoprotein I antibodies recognize specific epitopes on human β2 glycoprotein I which are expressed only when β2 glycoprotein I interacts with lipid membranes or when absorbed to other surfaces (e.g. microtiter plate). The assay is an aid in the diagnosis and risk of primary and secondary antiphospholipid syndrome. 30'+30'+30' automation incubation. FDA UDI
Identifiers
- Catalog Number
- 30-7205US FDA UDI
- Primary DI / UDI-DI
- 04250289502825 FDA UDI
- 510(k) Number
- K062217 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
Yes
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)
AESKULISA® ß2-Glyco-A by Aesku.Diagnostics GmbH & Co. KG — 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).
- Corgenix Anti-Beta 2 Glycoprotein I IgA Semi-Quantitative Test Kit (192 Well) — CORGENIX MEDICAL CORPORATION · 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
- DIASTAT anti-B2-Glycoprotein-1 IgM — Euro-Diagnostica AB · Class II
- REAADS Anti-Beta 2 Glycoprotein I IgA Semi-Quantitative Test Kit (96 Well) — CORGENIX MEDICAL CORPORATION · Class II
- EL-B2GPI IgM, IgG, IgA — THERATEST LABORATORIES, INC.
- REAADS Anti-Beta 2 Glycoprotein I IgG Semi-Quantitative Test Kit (96 Well) — CORGENIX MEDICAL CORPORATION · Class II
- Corgenix Anti-Beta 2 Glycoprotein I IgM Semi-Quantitative Test Kit (192 Well) — CORGENIX MEDICAL CORPORATION · Class II
Cleared under the same submission
K062217 also covers:
- AESKULISA® ß2-Glyco-A — Aesku.Diagnostics GmbH & Co. KG
- AESKULISA® ß2-Glyco-A — Aesku.Diagnostics GmbH & Co. KG
- AESKULISA® ß2-Glyco-Check — Aesku.Diagnostics GmbH & Co. KG
- AESKULISA® ß2-Glyco-Check — Aesku.Diagnostics GmbH & Co. KG
- AESKULISA® ß2-Glyco-Check — Aesku.Diagnostics GmbH & Co. KG
- AESKULISA® ß2-Glyco-GM — Aesku.Diagnostics GmbH & Co. KG
- AESKULISA® ß2-Glyco-GM — Aesku.Diagnostics GmbH & Co. KG
- AESKULISA® ß2-Glyco-GM — Aesku.Diagnostics GmbH & Co. KG
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Aesku.Diagnostics GmbH & Co. KG
Sources (1)
- FDA UDI 6110b877-cbce-46b6-9835-4218e2140b5a 36 fields · synced Jun 7, 2026