Identity
- Trade Name
- QUANTA Lite® RF IgM ELISA FDA UDI
- Generic Name
- Rheumatoid factor IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- 1. 1x RF IgM ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted RF IgM ELISA Calibrator A 4. 1x 1.2mL prediluted RF IgM ELISA Calibrator B 5. 1x 1.2mL prediluted RF IgM ELISA Calibrator C 6. 1x 1.2mL prediluted RF IgM ELISA Calibrator D 7. 1x 1.2mL prediluted RF IgM ELISA Calibrator E 8. 1x 1.2mL prediluted RF IgM ELISA Control 9. 1x 50mL HRP Sample Diluent 10.1x 25mL HRP Wash Concentrate, 40x concentrate 11. 1x 10mL HRP IgM Conjugate, (goat), anti-human IgM 12.1x 10mL TMB Chromogen 13.1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid FDA UDI
- Model / Reference
- 708690 FDA UDI
- Description
- 1. 1x RF IgM ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted RF IgM ELISA Calibrator A 4. 1x 1.2mL prediluted RF IgM ELISA Calibrator B 5. 1x 1.2mL prediluted RF IgM ELISA Calibrator C 6. 1x 1.2mL prediluted RF IgM ELISA Calibrator D 7. 1x 1.2mL prediluted RF IgM ELISA Calibrator E 8. 1x 1.2mL prediluted RF IgM ELISA Control 9. 1x 50mL HRP Sample Diluent 10.1x 25mL HRP Wash Concentrate, 40x concentrate 11. 1x 10mL HRP IgM Conjugate, (goat), anti-human IgM 12.1x 10mL TMB Chromogen 13.1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08426950593188 FDA UDI
- 510(k) Number
- K971614 FDA UDI
- FDA Product Code
- DHR FDA UDI
- GMDN Term
- Rheumatoid factor IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5775 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Rheumatoid factor IVD, kit, enzyme immunoassay (EIA)
QUANTA Lite® RF IgM ELISA by Inova Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Inova Diagnostics, Inc.
Sources (1)
- FDA UDI c04cadc2-6196-44d5-bdf3-a001f96a37de 36 fields · synced May 30, 2026