Identity
- Trade Name
- GEM Hematocrit Evaluator 3 FDA UDI
- Generic Name
- Red blood cell count IVD, control FDA UDI
- Device Name
- GEM Hematocrit Evaluator 3 FDA UDI
- Model / Reference
- 00025000106 FDA UDI
- Description
- GEM Hematocrit Evaluator 3 FDA UDI
Identifiers
- Catalog Number
- 00025000106 FDA UDI
- Primary DI / UDI-DI
- 08426950573685 FDA UDI
- FDA Product Code
- GLK FDA UDI
- GMDN Term
- Red blood cell count 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
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
No
FDA UDI
Category: Red blood cell count IVD, control
GEM Hematocrit Evaluator 3 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 4a68a93b-5dad-497b-83ff-5fa3a421f8fa 36 fields · synced May 30, 2026