Identity
- Trade Name
- QUANTA Flash EUDAMEDQUANTA Flash RF IgM Calibrators FDA UDI
- Generic Name
- Rheumatoid factor IVD, calibrator FDA UDI
- Device Name
- QUANTA Flash® RF IgM Calibrators EUDAMED1. QUANTA Flash RF IgM Calibrator 1: Two (2) barcode labeled tubes containing 0.3mL prediluted, ready to use reagent. Calibrators contain human antibodies to RF IgM in stabilizers and preservatives. 2. QUANTA Flash RF IgM Calibrator 2: Two (2) barcode labeled tubes containing 0.3mL prediluted, ready to use reagent. Calibrators contain human antibodies to RF IgM in stabilizers and preservatives. FDA UDI
- Model / Reference
- 701341 EUDAMEDFDA UDI
- Description
- 1. QUANTA Flash RF IgM Calibrator 1: Two (2) barcode labeled tubes containing 0.3mL prediluted, ready to use reagent. Calibrators contain human antibodies to RF IgM in stabilizers and preservatives. 2. QUANTA Flash RF IgM Calibrator 2: Two (2) barcode labeled tubes containing 0.3mL prediluted, ready to use reagent. Calibrators contain human antibodies to RF IgM in stabilizers and preservatives. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08426950845256 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08426950845256 EUDAMED
- FDA Product Code
- JIT FDA UDI
- EMDN Code
- W0102152211 STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY EUDAMED
- GMDN Term
- Rheumatoid factor 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
Single Use
Yes
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
Prescription Use
No
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
The QUANTA Flash RF IgM Calibrators are a high-quality, medical device used for detecting and measuring the presence of specific antibodies in patient samples. These calibrators are designed to ensure accurate and reliable testing, making them an essential tool in various clinical settings.
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/IVDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-08426950845256 | 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 9f96ab31-bb3e-458b-8a66-39373bd84532 61 fields · synced Jun 22, 2026
- FDA UDI 19651aff-e86a-485f-89ec-2725f7eb9457 35 fields · synced May 30, 2026