Identity
- Trade Name
- Stat Profile FDA UDI
- Generic Name
- Single-channel clinical chemistry analyser IVD, point-of-care FDA UDI
- Device Name
- Stat Profile Prime Plus MicroSensor Card™ BLANK FDA UDI
- Model / Reference
- Prime Plus FDA UDI
- Description
- Stat Profile Prime Plus MicroSensor Card™ BLANK FDA UDI
Identifiers
- Catalog Number
- 58379 FDA UDI
- Primary DI / UDI-DI
- 00385480583794 FDA UDI
- FDA Product Code
- CHL FDA UDI
- GMDN Term
- Single-channel clinical chemistry analyser IVD, point-of-care FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1120 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Single-channel clinical chemistry analyser IVD, point-of-care
Stat Profile by Nova Biomedical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Stat Profile — NOVA BIOMEDICAL CORPORATION · Class II
- Stat Profile — NOVA BIOMEDICAL CORPORATION · Class II
- Stat Profile — NOVA BIOMEDICAL CORPORATION · Class II
- Stat Profile — NOVA BIOMEDICAL CORPORATION · Class II
- Stat Profile — NOVA BIOMEDICAL CORPORATION · Class II
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 |
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Manufacturer
- Manufacturer
- Nova Biomedical Corporation
Sources (1)
- FDA UDI c7915462-8af0-44d6-a8d2-b80b6009d3d5 36 fields · synced Jun 8, 2026