HemosIL AcuStar Anti-B2GPI Domain 1
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- HemosIL AcuStar Anti-ß2GPI Domain 1 EUDAMEDHemosIL AcuStar Anti-B2GPI Domain 1 FDA UDI
- Generic Name
- Beta-2-microglobulin IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- HemosIL AcuStar Anti-ß2GPI Domain 1 EUDAMED1. HemosIL Acustar ß2GP1-Domain1 Reagent Cartridge (Cat. No. 00009800016 2. 1 Resuspension buffer (Cat. No. 00009800019) 3. 1 HemosIL Acustar ß2GP1-Domain1 Calibrator 1 (Cat. No. 00009800017): 4. 1 HemosIL Acustar ß2GP1-Domain1 Calibrator 2 (Cat. 00009800018): FDA UDI
- Model / Reference
- 00009800015 EUDAMEDFDA UDI
- Description
- 1. HemosIL Acustar ß2GP1-Domain1 Reagent Cartridge (Cat. No. 00009800016 2. 1 Resuspension buffer (Cat. No. 00009800019) 3. 1 HemosIL Acustar ß2GP1-Domain1 Calibrator 1 (Cat. No. 00009800017): 4. 1 HemosIL Acustar ß2GP1-Domain1 Calibrator 2 (Cat. 00009800018): FDA UDI
Identifiers
- Catalog Number
- 00009800015 FDA UDI
- Primary DI / UDI-DI
- 08426951298778 EUDAMEDFDA UDI
- Basic UDI-DI
- 8426951298778B8 EUDAMED
- Direct Marketing DI
- 08426951298778 EUDAMED
- 510(k) Number
- K152875 FDA UDI
- FDA Product Code
- MSV FDA UDI
- EMDN Code
- W0102100503 ANTI-B2-GLYCOPROTEIN I ANTIBODIES EUDAMED
- GMDN Term
- Beta-2-microglobulin IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 866.5660 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
Yes
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Beta-2-microglobulin IVD, kit, chemiluminescent immunoassay
HemosIL AcuStar Anti-B2GPI Domain 1 by Instrumentation Laboratory Company — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Beta-2-microglobulin IVD, kit, chemiluminescent immunoassay.
Cleared under the same submission
K152875 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Instrumentation Laboratory Company
Sources (2)
- FDA UDI 52b09778-563a-488c-838e-3652e8a29779 37 fields · synced Jun 19, 2026
- EUDAMED 9c4d86d7-9784-4b6c-82dc-c5082e093e00 61 fields · synced Jun 19, 2026