Identity
- Trade Name
- ChemSTAT Hematocrit Evaluator 1 FDA UDI
- Generic Name
- Multiple electrolyte IVD, control FDA UDI
- Device Name
- ChemSTAT Hematocrit Evaluator 1, 10 ampoules x 1.8 mL FDA UDI
- Model / Reference
- 00044000104 FDA UDI
- Description
- ChemSTAT Hematocrit Evaluator 1, 10 ampoules x 1.8 mL FDA UDI
Identifiers
- Catalog Number
- 00044000104 FDA UDI
- Primary DI / UDI-DI
- 08426951293827 FDA UDI
- FDA Product Code
- GLK FDA UDI
- GMDN Term
- Multiple electrolyte IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.8625 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
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
Yes
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 electrolyte IVD, control
ChemSTAT Hematocrit Evaluator 1 by Instrumentation Laboratory Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Instrumentation Laboratory Company
Sources (1)
- FDA UDI 3d5b1b42-d3d8-43f7-8a81-8d54a324c752 36 fields · synced May 31, 2026