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CoaguChek XS Pro Kit

FDA UDI

Class II (US FDA UDI)

by Roche Diagnostics Corp.

Identity

Trade Name
CoaguChek XS Pro Kit FDA UDI
Generic Name
Home-use/point-of-care coagulation analyser IVD, battery-powered FDA UDI
Model / Reference
5530199160 FDA UDI

Identifiers

Catalog Number
5530199160 FDA UDI
Primary DI / UDI-DI
00365702398108 FDA UDI
510(k) Number
K093460 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 Pro 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

K093460 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 abdbe685-9556-482a-9580-463990653311 35 fields · synced May 31, 2026