Identity
- Trade Name
- QUANTA Lite EUDAMEDQUANTA Lite® RNA Pol III ELISA FDA UDI
- Generic Name
- RNA polymerase III antibody (anti-Pol III) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- QUANTA Lite® RNA Pol III ELISA EUDAMED1. 1x RNA Pol III ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted, ready to use, ELISA Negative Control 3. 1x 1.2mL prediluted, ready to use, RNA Pol III ELISA Low Positive 4. 1x 1.2mL prediluted, ready to use, RNA Pol III 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
- 704555 EUDAMEDFDA UDI
- Description
- 1. 1x RNA Pol III ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted, ready to use, ELISA Negative Control 3. 1x 1.2mL prediluted, ready to use, RNA Pol III ELISA Low Positive 4. 1x 1.2mL prediluted, ready to use, RNA Pol III 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
- 08426950506362 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08426950506362 EUDAMED
- 510(k) Number
- K070066 FDA UDI
- FDA Product Code
- NYO FDA UDI
- EMDN Code
- W0102100199 AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER EUDAMED
- GMDN Term
- RNA polymerase III antibody (anti-Pol III) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 866.5100 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
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
QUANTA Lite by Inova Diagnostics, Inc. — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-08426950506362 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- Inova Diagnostics. Inc.
- EUDAMED SRN
- US-MF-000017851
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED bb240c8f-2146-4bf0-85d9-502db24334e3 61 fields · synced Jul 17, 2026
- FDA UDI 55f64029-c462-4b2d-94f3-a739a7bfcb4b 36 fields · synced May 30, 2026