Identity
- Trade Name
- QUANTA Flash EUDAMEDQUANTA Flash® β2GPI IgM Controls FDA UDI
- Generic Name
- Beta-2-glycoprotein I antibody IVD, control FDA UDI
- Device Name
- QUANTA Flash® B2GP1 IgM Controls EUDAMED1. QUANTA Flash ß2GP1 IgM Low Control 3 x 1 mL barcoded tubes of a solution with anti-ß2GP1 IgM in phosphate buffer containing bovine serum albimun, stabilizers and preservative. 2. QUANTA Flash ß2GP1 IgM High Control 3 x 1 mL barcoded tubes of a solution with anti-ß2GP1 IgM in phosphate buffer containing bovine serum albumin, stabilizers and preservative. FDA UDI
- Model / Reference
- 701252 EUDAMEDFDA UDI
- Description
- 1. QUANTA Flash ß2GP1 IgM Low Control 3 x 1 mL barcoded tubes of a solution with anti-ß2GP1 IgM in phosphate buffer containing bovine serum albimun, stabilizers and preservative. 2. QUANTA Flash ß2GP1 IgM High Control 3 x 1 mL barcoded tubes of a solution with anti-ß2GP1 IgM in phosphate buffer containing bovine serum albumin, stabilizers and preservative. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08426950595038 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08426950595038 EUDAMED
- 510(k) Number
- K091556 FDA UDI
- FDA Product Code
- JJX FDA UDI
- EMDN Code
- W0102152204 CARDIAC MARKER STANDARDS AND CALIBRATORS EUDAMED
- GMDN Term
- Beta-2-glycoprotein I antibody IVD, control FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1660 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
Yes
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Prescription Use
Yes
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
QUANTA Flash by Inova Diagnostics, Inc. — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-08426950595038 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- Inova Diagnostics. Inc.
- EUDAMED SRN
- US-MF-000017851
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED c7bc063d-0bc3-4e2e-a278-e6356425237e 61 fields · synced Jun 8, 2026
- FDA UDI 6282789f-5712-4252-a08d-621fdb29abdd 36 fields · synced May 30, 2026