Identity
- Trade Name
- QUANTA Lite® dsDNA ELISA FDA UDI
- Generic Name
- Double stranded DNA antibody (anti-dsDNA) IVD, calibrator FDA UDI
- Device Name
- 1. 1x dsDNA ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted dsDNA ELISA Positive 4. 1x 1.2mL prediluted dsDNA ELISA Calibrator 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
- 708510 FDA UDI
- Description
- 1. 1x dsDNA ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted dsDNA ELISA Positive 4. 1x 1.2mL prediluted dsDNA ELISA Calibrator 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
- 08426950454502 FDA UDI
- 510(k) Number
- K903898 FDA UDI
- FDA Product Code
- LLL FDA UDI
- GMDN Term
- Double stranded DNA antibody (anti-dsDNA) IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5100 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: Double stranded DNA antibody (anti-dsDNA) IVD, kit, enzyme immunoassay (EIA)Double stranded DNA antibody (anti-dsDNA) IVD, calibrator
QUANTA Lite® dsDNA 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 0d90e14f-9859-44a6-8be2-96b7635f235a 36 fields · synced Jun 8, 2026