Identity
- Trade Name
- NOVA FDA UDI
- Generic Name
- Buffered sample diluent IVD, manual FDA UDI
- Device Name
- NOVA 12, NOVA 14, NOVA 16 DILUTER PACK FDA UDI
- Model / Reference
- 12 FDA UDI
- Description
- NOVA 12, NOVA 14, NOVA 16 DILUTER PACK FDA UDI
Identifiers
- Catalog Number
- 15819 FDA UDI
- Primary DI / UDI-DI
- 00385480158190 FDA UDI
- 510(k) Number
- K963005 FDA UDI
- FDA Product Code
- JIX FDA UDI
- GMDN Term
- Buffered sample diluent IVD, manual FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1150 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
Yes
FDA UDI
Category: Buffered sample diluent IVD, manual
Nova by Nova Biomedical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K963005 also covers:
- NOVA — NOVA BIOMEDICAL CORPORATION
- NOVA — NOVA BIOMEDICAL CORPORATION
- NOVA — NOVA BIOMEDICAL CORPORATION
- NOVA — NOVA BIOMEDICAL CORPORATION
- NOVA — NOVA BIOMEDICAL CORPORATION
- NOVA — NOVA BIOMEDICAL CORPORATION
- NOVA — NOVA BIOMEDICAL CORPORATION
- NOVA — NOVA BIOMEDICAL CORPORATION
- NOVA — NOVA BIOMEDICAL CORPORATION
- NOVA — NOVA BIOMEDICAL CORPORATION
- NOVA — NOVA BIOMEDICAL CORPORATION
- NOVA — NOVA BIOMEDICAL CORPORATION
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nova Biomedical Corporation
Sources (1)
- FDA UDI e5325bad-28e6-49cf-805a-674d5d109c46 37 fields · synced Jun 8, 2026