Identity
- Trade Name
- Globe Scientific FDA UDI
- Generic Name
- Laboratory analyser cuvette IVD, single-use FDA UDI
- Device Name
- ORGANON TEKNIKA: Test Trays, for use with the Coag-A-Mate XM analyzer, 100/Box, 10 Boxes/Case FDA UDI
- Model / Reference
- 5112 FDA UDI
- Description
- ORGANON TEKNIKA: Test Trays, for use with the Coag-A-Mate XM analyzer, 100/Box, 10 Boxes/Case FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840095606349 FDA UDI
- FDA Product Code
- LXG FDA UDI
- GMDN Term
- Laboratory analyser cuvette IVD, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2050 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Globe Scientific by Globe Scientific, Llc — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Globe Scientific, Llc
Sources (1)
- FDA UDI f4ca2b1f-6ccc-4fa7-853b-5e4eb6732780 34 fields · synced May 30, 2026