Identity
- Trade Name
- QUANTA Lite EUDAMEDQUANTA Lite® Actin IgG ELISA FDA UDI
- Generic Name
- F-Actin antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- QUANTA Lite® Actin IgG ELISA EUDAMED1.1x Actin IgG ELISA microwell plate (12-1 x 8 wells), with holder 2.1x 1.2mL prediluted ELISA Negative Control 3.1x 1.2mL prediluted Actin IgG ELISA Low Positive 4.1x 1.2mL prediluted Actin 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
- 708785 EUDAMEDFDA UDI
- Description
- 1.1x Actin IgG ELISA microwell plate (12-1 x 8 wells), with holder 2.1x 1.2mL prediluted ELISA Negative Control 3.1x 1.2mL prediluted Actin IgG ELISA Low Positive 4.1x 1.2mL prediluted Actin 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
- 08426950485094 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08426950485094 EUDAMED
- 510(k) Number
- K021648 FDA UDI
- FDA Product Code
- NJF FDA UDI
- EMDN Code
- W0102100701 HEPATITIS AUTOANTIBODY SCREENING EUDAMED
- GMDN Term
- F-Actin antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 866.5120 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-08426950485094 | 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 130cc66a-7ee3-423d-be74-c0473512d7c0 61 fields · synced May 30, 2026
- FDA UDI a05d94ab-2e3c-4ec3-8259-c0d71394d3b9 36 fields · synced May 30, 2026