Identity
- Trade Name
- GEM Test ACT-LR Cartridges FDA UDI
- Generic Name
- Activated clotting time (ACT) IVD, kit, clotting FDA UDI
- Device Name
- GEM Test ACT-LR Cartridges FDA UDI
- Model / Reference
- 06260040000 FDA UDI
- Description
- GEM Test ACT-LR Cartridges FDA UDI
Identifiers
- Catalog Number
- 06260040000 FDA UDI
- Primary DI / UDI-DI
- 08426950088608 FDA UDI
- FDA Product Code
- JPA FDA UDI
- GMDN Term
- Activated clotting time (ACT) IVD, kit, clotting FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.5425 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
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
GEM Test ACT-LR Cartridges by Instrumentation Laboratory Company — 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
- Instrumentation Laboratory Company
Sources (1)
- FDA UDI aa4a53d8-e8b2-413b-a8dd-73a0557328b1 37 fields · synced May 30, 2026