Identity
- Trade Name
- QUANTA Flash EUDAMEDQUANTA Flash® β2GPI IgA Controls FDA UDI
- Generic Name
- Beta-2-glycoprotein I antibody IVD, control FDA UDI
- Device Name
- QUANTA Flash® B2GP1 IgA Controls EUDAMED1. QUANTA Flash ß2GP1 IgA Low Control: 3 x 1 mL barcoded tubes of a solution with anti- ß2GP1 IgA in phosphate buffer, containing bovine serum albumin, stabilizers and preservative. 2. QUANTA Flash ß2GP1 IgA High Control: 3 x 1 mL barcoded tubes of a solution with anti- ß2GP1 IgA in phosphate buffer, containing bovine serum albumin, stabilizers and preservative. FDA UDI
- Model / Reference
- 701242 EUDAMEDFDA UDI
- Description
- 1. QUANTA Flash ß2GP1 IgA Low Control: 3 x 1 mL barcoded tubes of a solution with anti- ß2GP1 IgA in phosphate buffer, containing bovine serum albumin, stabilizers and preservative. 2. QUANTA Flash ß2GP1 IgA High Control: 3 x 1 mL barcoded tubes of a solution with anti- ß2GP1 IgA in phosphate buffer, containing bovine serum albumin, stabilizers and preservative. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08426950597353 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08426950597353 EUDAMED
- 510(k) Number
- K120817 FDA UDI
- FDA Product Code
- JJX FDA UDI
- EMDN Code
- W0102100503 ANTI-B2-GLYCOPROTEIN I ANTIBODIES 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
Yes
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-08426950597353 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Inova Diagnostics. Inc.
- EUDAMED SRN
- US-MF-000017851
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED 09077695-a245-4a4a-9efb-1c92f4032781 61 fields · synced May 30, 2026
- FDA UDI 1e2ed1a8-b38d-4585-bbc6-7829adcab515 36 fields · synced May 30, 2026