Identity
- Trade Name
- CoaguChek XS Patient Self Testing Care Kit FDA UDI
- Generic Name
- Cancer antigen 15-3 (CA15-3) IVD, antibody FDA UDI
- Model / Reference
- 03666794001 FDA UDI
Identifiers
- Catalog Number
- 03666794001 FDA UDI
- Primary DI / UDI-DI
- 04015630945689 FDA UDI
- 510(k) Number
- K062925 FDA UDI
- FDA Product Code
- GJS FDA UDI
- GMDN Term
- Cancer antigen 15-3 (CA15-3) IVD, antibody 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cancer antigen 15-3 (CA15-3) IVD, antibody
CoaguChek XS Patient Self Testing Care Kit by Roche Diagnostics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cancer antigen 15-3 (CA15-3) IVD, antibody.
- IHC — Slmp, LLC · Class I
- IHC — Slmp, LLC · Class I
- IHC — Slmp, LLC · Class I
- CoaguChek Vantus System — Roche Diagnostics Corp. · Class II
Cleared under the same submission
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Roche Diagnostics Corp.
Sources (1)
- FDA UDI 251487ff-9776-4511-a45f-de28ec6873c2 35 fields · synced May 30, 2026