Identity
- Trade Name
- Meter Trax FDA UDI
- Generic Name
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, control FDA UDI
- Device Name
- Meter Trax Control Trilevel MiniPak (A human whole blood control for glucose, hemoglobin and hematocrit.) FDA UDI
- Model / Reference
- 970X FDA UDI
- Description
- Meter Trax Control Trilevel MiniPak (A human whole blood control for glucose, hemoglobin and hematocrit.) FDA UDI
Identifiers
- Catalog Number
- 970X FDA UDI
- Primary DI / UDI-DI
- 00847661003182 FDA UDI
- 510(k) Number
- K042336 FDA UDI
- FDA Product Code
- JPK FDA UDIJJY FDA UDI
- GMDN Term
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.8625 FDA UDI862.1660 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
No
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
No
FDA UDI
Category: Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
Meter Trax by Bio-Rad Laboratories — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple blood gas/haemoximetry/electrolyte analyte IVD, control.
- RANGE+ QUALICHECK LEV. 1 S7930 — Radiometer Medical ApS · Class I
- STAT PROFILE — NOVA BIOMEDICAL CORPORATION · Class I
- Avox-4 CO-Oximeter Control - L2 — INSTRUMENTATION LABORATORY COMPANY · Class I
- i-STAT — Abbott Point of Care Inc. · Class I
- RAPIDSystems™ AutomaticQC Cartridge — Siemens Healthcare Diagnostics · Class II
- Bi-Level Quality Control Kit — Medica Corp. · Class II
- HIGH METABOLITE QC, LEVEL 1 — Radiometer Medical ApS · Class I
- Stat Profile — NOVA BIOMEDICAL CORPORATION · Class II
Cleared under the same submission
K042336 also covers:
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
- Bio-Rad Laboratories
Sources (1)
- FDA UDI 10e403a2-d15c-4aec-9a2a-09fec4451e18 37 fields · synced May 31, 2026