Identity
- Trade Name
- MedTest DX Lactate Standard FDA UDI
- Generic Name
- Lactate IVD, calibrator FDA UDI
- Device Name
- Lactate Standard, intended for use as an Lactate standard for standardization or calibration of Lactate Oxidase, Lactate procedures. Size: 1 x15 ml FDA UDI
- Model / Reference
- LACS480 FDA UDI
- Description
- Lactate Standard, intended for use as an Lactate standard for standardization or calibration of Lactate Oxidase, Lactate procedures. Size: 1 x15 ml FDA UDI
Identifiers
- Catalog Number
- LACS480 FDA UDI
- Primary DI / UDI-DI
- 00817439020970 FDA UDI
- FDA Product Code
- CFJ FDA UDI
- GMDN Term
- Lactate IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1440 FDA UDI
- Commercial Distribution
- Not 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
Yes
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
No
FDA UDI
MedTest DX Lactate Standard by Medtest DX — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Medtest DX
Sources (1)
- FDA UDI 4fe5f657-0dd1-45a7-b5e6-56bae6ad13a4 37 fields · synced May 30, 2026