Identity
- Trade Name
- QUANTA Lite® CCP3.1 IgG/IgA ELISA FDA UDI
- Generic Name
- Rheumatoid factor IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- 1. 1x CCP3.1 IgG/IgA ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted CCP3.1 IgG/IgA ELISA Low Positive 4. 1x 1.2mL prediluted CCP3.1 IgG/IgA ELISA High Positive/Calibrator A 5. 1x 1.2mL prediluted CCP3.1 IgG/IgA ELISA Calibrator B 6. 1x 1.2mL prediluted CCP3.1 IgG/IgA ELISA Calibrator C 7. 1x 1.2mL prediluted CCP3.1 IgG/IgA ELISA Calibrator D 8. 1x 1.2mL prediluted CCP3.1 IgG/IgA ELISA Calibrator E 9. 1x 50mL HRP Sample Diluent 10. 1x 100mL High Specificity Wash Concentrate, 10x concentrate 11. 1x 10mL HRP CCP3.1 IgG/IgA Conjugate, (goat), anti-human IgG/IgA 12. 1x 10mL TMB Chromogen 13. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid FDA UDI
- Model / Reference
- 704550 FDA UDI
- Description
- 1. 1x CCP3.1 IgG/IgA ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted CCP3.1 IgG/IgA ELISA Low Positive 4. 1x 1.2mL prediluted CCP3.1 IgG/IgA ELISA High Positive/Calibrator A 5. 1x 1.2mL prediluted CCP3.1 IgG/IgA ELISA Calibrator B 6. 1x 1.2mL prediluted CCP3.1 IgG/IgA ELISA Calibrator C 7. 1x 1.2mL prediluted CCP3.1 IgG/IgA ELISA Calibrator D 8. 1x 1.2mL prediluted CCP3.1 IgG/IgA ELISA Calibrator E 9. 1x 50mL HRP Sample Diluent 10. 1x 100mL High Specificity Wash Concentrate, 10x concentrate 11. 1x 10mL HRP CCP3.1 IgG/IgA Conjugate, (goat), anti-human IgG/IgA 12. 1x 10mL TMB Chromogen 13. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08426950456124 FDA UDI
- 510(k) Number
- K072944 FDA UDI
- FDA Product Code
- NHX 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® CCP3.1 IgG/IgA ELISA by Inova Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K072944 also covers:
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 96ff858a-9aa9-427f-8b22-a6e3f02af02a 36 fields · synced Jun 6, 2026