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Berichrom® Protein C

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics Products Ltd

Identity

Trade Name
Berichrom® Protein C FDA UDI
Generic Name
Protein C IVD, kit, chromogenic FDA UDI
Device Name
Quantative determination of protein C activity as an aid in the diagnosis of inherited and acquired deficiencies FDA UDI
Model / Reference
10446499 FDA UDI
Description
Quantative determination of protein C activity as an aid in the diagnosis of inherited and acquired deficiencies FDA UDI

Identifiers

Catalog Number
OUVV15 FDA UDI
Primary DI / UDI-DI
00842768011900 FDA UDI
510(k) Number
K890634 FDA UDI
FDA Product Code
GGP FDA UDI
GMDN Term
Protein C IVD, kit, chromogenic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.7290 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

No

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: Protein C IVD, kit, chromogenic

Berichrom® Protein C by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Protein C IVD, kit, chromogenic.

Cleared under the same submission

K890634 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Siemens Healthcare Diagnostics Products Ltd

Sources (1)

  • FDA UDI b3906e19-4b11-4706-9876-9d913fd754b2 37 fields · synced May 30, 2026