Identity
- Trade Name
- NOVA Lite® HEp-2 ANA Plus Mouse Kidney & Stomach FDA UDI
- Generic Name
- Intrinsic factor/parietal cell antibody IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- 1. 20x 4-well ANA Plus Substrate Slides 2. 1x 15mL FITC Anti-Human IgG Conjugate 3. 1x 0.5mL ANA Homogeneous Pattern 4. 1x 0.5mL IFA System Negative Control 5. 2x 25mL PBS Concentrate (40x) 6. 1x 7mL Mounting Medium 7. 1x 20 Coverslips FDA UDI
- Model / Reference
- 708155 FDA UDI
- Description
- 1. 20x 4-well ANA Plus Substrate Slides 2. 1x 15mL FITC Anti-Human IgG Conjugate 3. 1x 0.5mL ANA Homogeneous Pattern 4. 1x 0.5mL IFA System Negative Control 5. 2x 25mL PBS Concentrate (40x) 6. 1x 7mL Mounting Medium 7. 1x 20 Coverslips FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08426950596387 FDA UDI
- 510(k) Number
- K881339 FDA UDI
- FDA Product Code
- LLL FDA UDI
- GMDN Term
- Intrinsic factor/parietal cell antibody IVD, kit, fluorescent immunoassay 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
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassayMitochondrial antibody M2 (anti-Mi2) IVD, kit, fluorescent immunoassaySmooth muscle antibody IVD, kit, fluorescent immunoassayIntrinsic factor/parietal cell antibody IVD, kit, fluorescent immunoassay
NOVA Lite® HEp-2 ANA Plus Mouse Kidney & Stomach by Inova Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intrinsic factor/parietal cell antibody IVD, kit, fluorescent immunoassay.
- MeDiCa — Scimedx Corp. · Class II
- MeDiCa — Scimedx Corp. · Class II
- MeDiCa — Scimedx Corp. · Class II
- Histofluor® Rodent LKS Fluorescent Antibody Test System — IMMUNO CONCEPTS INC
- MeDiCa — Scimedx Corp. · Class II
- MeDiCa — Scimedx Corp. · Class II
- Histofluor® Rodent LKS Fluorescent Antibody Test System — IMMUNO CONCEPTS INC
- Histofluor® Rodent LKS Fluorescent Antibody Test System — IMMUNO CONCEPTS INC
Cleared under the same submission
K881339 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Inova Diagnostics, Inc.
Sources (1)
- FDA UDI 4dc4b3b3-235c-42f5-9aa5-9f59ebe8da31 36 fields · synced May 31, 2026