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CoaguChek XS Professional Use Care Kit

FDA UDI

Class II (US FDA UDI)

by Roche Diagnostics Corp.

Identity

Trade Name
CoaguChek XS Professional Use Care Kit FDA UDI
Generic Name
Home-use/point-of-care coagulation analyser IVD, battery-powered FDA UDI
Model / Reference
4837975001 FDA UDI

Identifiers

Catalog Number
4837975001 FDA UDI
Primary DI / UDI-DI
00365702126107 FDA UDI
510(k) Number
K060978 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

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

Yes

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

Yes

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 Professional Use Care Kit 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.

Cleared under the same submission

K060978 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Roche Diagnostics Corp.

Sources (1)

  • FDA UDI e9702845-c1c4-42bc-9429-91453e1dfb66 35 fields · synced Jun 8, 2026