Identity
- Trade Name
- QUANTA Lite® PR-3 IgG ELISA FDA UDI
- Generic Name
- Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- 1. 1x PR-3 IgG ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted PR-3 IgG ELISA Low Positive 4. 1x 1.2mL prediluted PR-3 IgG ELISA High Positive 5. 1x 50mL HRP Sample Diluent 6. 1x 25mL HRP Wash Concentrate, 40x concentrate 7. 1x 10mL HRP IgG Conjugate, (goat), anti-human IgG 8. 1x 10mL TMB Chromogen 9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid FDA UDI
- Model / Reference
- 708705 FDA UDI
- Description
- 1. 1x PR-3 IgG ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted PR-3 IgG ELISA Low Positive 4. 1x 1.2mL prediluted PR-3 IgG ELISA High Positive 5. 1x 50mL HRP Sample Diluent 6. 1x 25mL HRP Wash Concentrate, 40x concentrate 7. 1x 10mL HRP IgG Conjugate, (goat), anti-human IgG 8. 1x 10mL TMB Chromogen 9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08426950448303 FDA UDI
- 510(k) Number
- K981328 FDA UDI
- FDA Product Code
- MOB FDA UDI
- GMDN Term
- Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5660 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: Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD, kit, enzyme immunoassay (EIA)Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD, reagent
QUANTA Lite® PR-3 IgG 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 63d19e0f-b747-42da-a918-98ebb846c2c3 36 fields · synced May 30, 2026