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Coagulation Factor XI Deficient Plasma

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics Products Ltd

Identity

Trade Name
Coagulation Factor XI Deficient Plasma FDA UDI
Generic Name
Coagulation factor XI IVD, reagent FDA UDI
Device Name
For the determination of the activity of coagulation factor XI in human plasma by coagulometric methods FDA UDI
Model / Reference
10446316 FDA UDI
Description
For the determination of the activity of coagulation factor XI in human plasma by coagulometric methods FDA UDI

Identifiers

Catalog Number
OSDF13 FDA UDI
Primary DI / UDI-DI
00842768009976 FDA UDI
510(k) Number
K924396 FDA UDI
FDA Product Code
GJT FDA UDI
GMDN Term
Coagulation factor XI IVD, reagent 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: Coagulation factor XI IVD, reagent

Coagulation Factor XI Deficient Plasma by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Coagulation factor XI IVD, reagent.

Cleared under the same submission

K924396 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 a8f9e1fc-c200-41af-a566-72cd4c5f0c42 37 fields · synced May 30, 2026