Identity
- Trade Name
- NOVA Lite EUDAMEDNOVA Lite®Rat Liver , Kidney, Stomach Kit FDA UDI
- Generic Name
- Intrinsic factor/parietal cell antibody IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- NOVA Lite® Rat Liver, Kidney, Stomach Kit EUDAMED1. 10 x Rat liver, kidney, stomach slide (5-well) 2. 1 x 1mL ANA Homogeneous Pattern (prediluted) 3. 1 x 1mL IFA System Negative Control (prediluted) 4. 1 x 1mL Mitochondrial (AMA) Pattern (prediluted) 5. 1 x 1mL Smooth Muscle (ASMA) Pattern (prediluted) 6. 1 x 7mL FITC IgG (H&L) Conjugate 7. 1 x 3mL 1% Evans Blue Counterstain 8. 2 x 25mL PBS II Buffer (x40 conc) 9. 1 x 3mL Mounting Medium 10. 20 x Blotters 11. 10 x Coverslips 12. 1 x instruction leaflet FDA UDI
- Model / Reference
- 704170 EUDAMEDFDA UDI
- Description
- 1. 10 x Rat liver, kidney, stomach slide (5-well) 2. 1 x 1mL ANA Homogeneous Pattern (prediluted) 3. 1 x 1mL IFA System Negative Control (prediluted) 4. 1 x 1mL Mitochondrial (AMA) Pattern (prediluted) 5. 1 x 1mL Smooth Muscle (ASMA) Pattern (prediluted) 6. 1 x 7mL FITC IgG (H&L) Conjugate 7. 1 x 3mL 1% Evans Blue Counterstain 8. 2 x 25mL PBS II Buffer (x40 conc) 9. 1 x 3mL Mounting Medium 10. 20 x Blotters 11. 10 x Coverslips 12. 1 x instruction leaflet FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08426950514176 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08426950514176 EUDAMED
- 510(k) Number
- K955431 FDA UDI
- FDA Product Code
- DBL FDA UDI
- EMDN Code
- W0102100101,W0102109099 EUDAMED
- GMDN Term
- Intrinsic factor/parietal cell antibody IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 866.5660 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
NOVA 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-08426950514176 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Inova Diagnostics. Inc.
- EUDAMED SRN
- US-MF-000017851
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED 373ae7b2-8ae1-45cb-b67b-0d3d774be2fb 61 fields · synced Jul 9, 2026
- FDA UDI 83c5e2b9-5480-4417-8cdd-c3f0207efe44 36 fields · synced May 30, 2026