Identity
- Trade Name
- NOVA FDA UDI
- Generic Name
- Lactate IVD, control FDA UDI
- Device Name
- Nova StatStrip LAC Control, Level 1 FDA UDI
- Model / Reference
- STATSTRIP LAC FDA UDI
- Description
- Nova StatStrip LAC Control, Level 1 FDA UDI
Identifiers
- Catalog Number
- 47553 FDA UDI
- Primary DI / UDI-DI
- 00385480475532 FDA UDI
- 510(k) Number
- K112955 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Lactate IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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: Lactate IVD, control
Nova by Nova Biomedical Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Lactate IVD, control.
- THE EDGE Lactate Control Solution — APEX BIOTECHNOLOGY CORP. · Class I
- NOVA — NOVA BIOMEDICAL CORPORATION · Class I
- Lactate Plus — NOVA BIOMEDICAL CORPORATION · Class I
- NOVA — NOVA BIOMEDICAL CORPORATION · Class I
- STATSTRIP — NOVA BIOMEDICAL CORPORATION · Class I
- Lactate Plus — NOVA BIOMEDICAL CORPORATION · Class I
Cleared under the same submission
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 08dd2a79-a015-46d0-a561-9308f9ab669b 37 fields · synced Jun 8, 2026