Identity
- Trade Name
- AESKULISA® ß2-Glyco-Check FDA UDI
- Generic Name
- Anticardiolipin-B2-glycoprotein I complex antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- AESKULISA β2-Glyco-Check is a solid phase enzyme immunoassay employing native β2glycoproteinI highly purified from human plasma for the combined quantitative and qualitative detection of IgA, IgG and IgM antibodies against β2-glycoprotein I in human serum. Anti-β2glycoprotein 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 (APS). FDA UDI
- Model / Reference
- 7215US FDA UDI
- Description
- AESKULISA β2-Glyco-Check is a solid phase enzyme immunoassay employing native β2glycoproteinI highly purified from human plasma for the combined quantitative and qualitative detection of IgA, IgG and IgM antibodies against β2-glycoprotein I in human serum. Anti-β2glycoprotein 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 (APS). FDA UDI
Identifiers
- Catalog Number
- 7215US FDA UDI
- Primary DI / UDI-DI
- 04250289503099 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-Check 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).
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- 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
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- 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-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-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 |
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Manufacturer
- Manufacturer
- Aesku.Diagnostics GmbH & Co. KG
Sources (1)
- FDA UDI 843ca4f5-553e-468d-873c-e7f717f53b8b 36 fields · synced May 31, 2026