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CoaguChek XS Plus Professional Care Kit

FDA UDI

Class II (US FDA UDI)

by Roche Diagnostics Corp.

Identity

Trade Name
CoaguChek XS Plus Professional Care Kit FDA UDI
Generic Name
Coagulation analyser IVD, point-of-care, battery-powered FDA UDI
Model / Reference
04562780001 FDA UDI

Identifiers

Catalog Number
04562780001 FDA UDI
Primary DI / UDI-DI
04015630945726 FDA UDI
510(k) Number
K071041 FDA UDI
FDA Product Code
GJS FDA UDI
GMDN Term
Coagulation analyser IVD, point-of-care, 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

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: Coagulation analyser IVD, point-of-care, battery-powered

CoaguChek XS Plus Professional Care Kit by Roche Diagnostics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Coagulation analyser IVD, point-of-care, battery-powered.

Cleared under the same submission

K071041 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 daa73e62-fdcb-44f2-9ff7-ab19789c7240 35 fields · synced Jun 8, 2026