Identity
- Trade Name
- QUANTA Flash EUDAMEDQUANTA Flash® GBM Calibrators FDA UDI
- Generic Name
- Glomerular basement membrane antibody (Goodpasture antibody) IVD, calibrator FDA UDI
- Device Name
- QUANTA Flash® GBM Calibrators EUDAMED1. QUANTA Flash GBM Calibrator 1: Two (2) barcode labeled tubes with buffer containing human serum antibodies to GBM, prediluted, ready to use, 0.7mL (containing buffer, protein stabilizers, and preservatives). 2. QUANTA Flash GBM Calibrator 2: Two (2) barcode labeled tubes with buffer containing human serum antibodies to GBM, prediluted, ready to use, 0.7mL (containing buffer, protein stabilizers, and preservatives). FDA UDI
- Model / Reference
- 701141 EUDAMEDFDA UDI
- Description
- 1. QUANTA Flash GBM Calibrator 1: Two (2) barcode labeled tubes with buffer containing human serum antibodies to GBM, prediluted, ready to use, 0.7mL (containing buffer, protein stabilizers, and preservatives). 2. QUANTA Flash GBM Calibrator 2: Two (2) barcode labeled tubes with buffer containing human serum antibodies to GBM, prediluted, ready to use, 0.7mL (containing buffer, protein stabilizers, and preservatives). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08426950595120 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08426950595120 EUDAMED
- 510(k) Number
- K112545 FDA UDI
- FDA Product Code
- JIX FDA UDI
- EMDN Code
- W0102152211 STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY EUDAMED
- GMDN Term
- Glomerular basement membrane antibody (Goodpasture antibody) IVD, calibrator FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1150 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-08426950595120 | 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 ad81619c-1c36-4598-98ea-757aca813d2f 61 fields · synced Jul 27, 2026
- FDA UDI c6760674-c15b-4b35-b839-5fd048f9e5e6 36 fields · synced May 25, 2026