Identity
- Trade Name
- NOVA FDA UDI
- Generic Name
- Metabolic profile clinical chemistry analyser IVD, portable, semi-automated FDA UDI
- Device Name
- Microsample Tube Kit 50 ul Nova CRT FDA UDI
- Model / Reference
- CRT FDA UDI
- Description
- Microsample Tube Kit 50 ul Nova CRT FDA UDI
Identifiers
- Catalog Number
- 14253 FDA UDI
- Primary DI / UDI-DI
- 00385480142533 FDA UDI
- 510(k) Number
- K963005 FDA UDI
- FDA Product Code
- JJC FDA UDINDW FDA UDIJPK FDA UDIJIX FDA UDICEM FDA UDIJPI FDA UDICFA FDA UDICGL FDA UDIJFL FDA UDIJFP FDA UDICGA FDA UDIJGS FDA UDICDS FDA UDICGZ FDA UDI
- GMDN Term
- Metabolic profile clinical chemistry analyser IVD, portable, semi-automated FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2150 FDA UDI862.3560 FDA UDI864.8625 FDA UDI862.1150 FDA UDI862.1600 FDA UDI864.6400 FDA UDI862.1495 FDA UDI862.1225 FDA UDI862.1160 FDA UDI862.1145 FDA UDI862.1345 FDA UDI862.1665 FDA UDI862.1770 FDA UDI862.1170 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
Nova by Nova Biomedical Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Metabolic profile clinical chemistry analyser IVD, portable, semi-automated.
- NOVA — NOVA BIOMEDICAL CORPORATION · Class II
- NOVA — NOVA BIOMEDICAL CORPORATION · Class II
- STAT PROFILE — NOVA BIOMEDICAL CORPORATION · Class II
- NOVA — NOVA BIOMEDICAL CORPORATION · Class II
- NOVA — NOVA BIOMEDICAL CORPORATION · Class II
- Nova — NOVA BIOMEDICAL CORPORATION · Class II
- STAT PROFILE — NOVA BIOMEDICAL CORPORATION · Class II
- STAT PROFILE — NOVA BIOMEDICAL CORPORATION · Class II
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nova Biomedical Corporation
Sources (1)
- FDA UDI 3af53bbd-498e-4eb8-b311-c9c86a2ac6eb 36 fields · synced Jun 8, 2026