Identity
- Trade Name
- iFlash-β2-Glycoprotein I IgM EUDAMEDiFlash-Beta2-Glycoprotein I IgM FDA UDI
- Generic Name
- Beta-2-glycoprotein I antibody IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- iFlash-β2-Glycoprotein I IgM EUDAMED"Beta" is identical to the second letter of Greek alphabet. Because GUDID system couldn't recognize this letter, it is replaced by "Beta". The acutal product name would be showed with the second letter of Greek alphabet instead of "Beta". FDA UDI
- Model / Reference
- C89052M EUDAMEDFDA UDI
- Description
- "Beta" is identical to the second letter of Greek alphabet. Because GUDID system couldn't recognize this letter, it is replaced by "Beta". The acutal product name would be showed with the second letter of Greek alphabet instead of "Beta". FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06925912718840 EUDAMEDFDA UDI
- Basic UDI-DI
- 692591270034H2 EUDAMED
- FDA Product Code
- DDN FDA UDI
- EMDN Code
- W0102100503 ANTI-B2-GLYCOPROTEIN I ANTIBODIES EUDAMED
- GMDN Term
- Beta-2-glycoprotein I antibody IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 866.5430 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
Yes
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
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Beta-2-glycoprotein I antibody IVD, kit, chemiluminescent immunoassay
iFlash-Beta2-Glycoprotein I IgM by Shenzhen YHLO Biotech Co., Ltd. — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Beta-2-glycoprotein I antibody IVD, kit, chemiluminescent immunoassay.
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen YHLO Biotech Co., Ltd.
Sources (2)
- FDA UDI ab621236-00d4-4fd0-a757-dda19ba099ab 33 fields · synced Jun 18, 2026
- EUDAMED b4393aef-0129-40c1-8ccb-d0ebb2882dcc 61 fields · synced Jun 18, 2026