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Factor V Leiden

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics Products Ltd

Identity

Trade Name
Factor V Leiden FDA UDI
Generic Name
Activated protein C resistance ratio (APCR) IVD, kit, clotting FDA UDI
Device Name
Russell Viper Venom-based test for screening of resistance to Activated Protein C (APC) in plasma from individuals with the Factor V (Leiden) defect FDA UDI
Model / Reference
10459420 FDA UDI
Description
Russell Viper Venom-based test for screening of resistance to Activated Protein C (APC) in plasma from individuals with the Factor V (Leiden) defect FDA UDI

Identifiers

Catalog Number
OQYI11 FDA UDI
Primary DI / UDI-DI
00842768033520 FDA UDI
510(k) Number
K992456 FDA UDI
FDA Product Code
GGW FDA UDI
GMDN Term
Activated protein C resistance ratio (APCR) IVD, kit, clotting FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.7925 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: Activated protein C resistance ratio (APCR) IVD, kit, clotting

Factor V Leiden by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Activated protein C resistance ratio (APCR) IVD, kit, clotting.

Cleared under the same submission

K992456 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 b477d26f-22e1-4d7f-8bc9-295231c6be72 37 fields · synced May 29, 2026