Identity
- Trade Name
- CoaguChek XS PT strips FDA UDI
- Generic Name
- Home-use/point-of-care coagulation analyser IVD, battery-powered FDA UDI
- Model / Reference
- 7797826160 FDA UDI
Identifiers
- Catalog Number
- 7797826160 FDA UDI
- Primary DI / UDI-DI
- 04015630946471 FDA UDI
- FDA Product Code
- GJS FDA UDI
- GMDN Term
- Home-use/point-of-care coagulation analyser IVD, battery-powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7750 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
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: Home-use/point-of-care coagulation analyser IVD, battery-powered
CoaguChek XS PT strips by Roche Diagnostics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Home-use/point-of-care coagulation analyser IVD, battery-powered.
- COAGUCHEK XS PT TEST 6 STRIP — Roche Diagnostics Corp. · Class II
- CoaguChek XS Plus Professional Care Kit — Roche Diagnostics Corp. · Class II
- CoaguChek XS Patient Self Testing Care Kit — Roche Diagnostics Corp. · Class II
- CoaguChek XS Pro Kit — Roche Diagnostics Corp. · Class II
- CoaguChek XS PT strips — Roche Diagnostics Corp. · Class II
- CoaguChek XS Professional Use Care Kit — Roche Diagnostics Corp. · Class II
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
- Roche Diagnostics Corp.
Sources (1)
- FDA UDI bd213b8a-a2cc-4859-b0ba-821acb1e8a9d 34 fields · synced May 30, 2026