Identity
- Trade Name
- TEMPERATURE PROBE FDA UDI
- Generic Name
- Coagulation analyser IVD, laboratory, semi-automated FDA UDI
- Device Name
- TEMPERATURE PROBE FDA UDI
- Model / Reference
- 06320480210 FDA UDI
- Description
- TEMPERATURE PROBE FDA UDI
Identifiers
- Catalog Number
- 06320480210 FDA UDI
- Primary DI / UDI-DI
- 08426950452614 FDA UDI
- 510(k) Number
- K951485 FDA UDI
- FDA Product Code
- JKS FDA UDI
- GMDN Term
- Coagulation analyser IVD, laboratory, semi-automated FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.3220 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Coagulation analyser IVD, laboratory, semi-automated
Temperature Probe by Instrumentation Laboratory Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Coagulation analyser IVD, laboratory, semi-automated.
- BFT II Analyzer — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Cuvettes for BFT // Analyzer — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Hemochron Whole Blood Coagulation System — ACCRIVA DIAGNOSTICS HOLDINGS, INC. · Class II
- ST art® — DIAGNOSTICA STAGO, INC. · Class II
- ROTEM® — Tem Innovations GmbH · Class II
- BFT II Analyzer Dispo System — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
Cleared under the same submission
K951485 also covers:
- Avoximeter Whole Blood CO-Oximeter — ACCRIVA DIAGNOSTICS HOLDINGS, INC.
- Avoximeter Whole Blood CO-Oximeter — ACCRIVA DIAGNOSTICS HOLDINGS, INC.
- Avoximeter Whole Blood CO-Oximeter — ACCRIVA DIAGNOSTICS HOLDINGS, INC.
- Avoximeter Whole Blood CO-Oximeter — ACCRIVA DIAGNOSTICS HOLDINGS, INC.
- GEM OPL CUVETTES — INSTRUMENTATION LABORATORY COMPANY
- OPTICAL QC FILTERS — INSTRUMENTATION LABORATORY COMPANY
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 |
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Manufacturer
- Manufacturer
- Instrumentation Laboratory Company
Sources (1)
- FDA UDI 6db56f61-309b-42a0-be9c-10edda1cfa3a 37 fields · synced Jun 8, 2026