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N Antiserum to Human Plasminogen

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics Products Ltd

Identity

Trade Name
N Antiserum to Human Plasminogen FDA UDI
Generic Name
Plasminogen IVD, reagent FDA UDI
Device Name
Quantitative determination of plasminogen in human plasma on BN Systems FDA UDI
Model / Reference
10446314 FDA UDI
Description
Quantitative determination of plasminogen in human plasma on BN Systems FDA UDI

Identifiers

Catalog Number
OSCB09 FDA UDI
Primary DI / UDI-DI
00842768009952 FDA UDI
510(k) Number
K860894 FDA UDI
FDA Product Code
CFN FDA UDI
GMDN Term
Plasminogen IVD, reagent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5510 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: Plasminogen IVD, reagent

N Antiserum to Human Plasminogen by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K860894 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 638b6bce-19a0-4acc-a24a-0f40869b0005 37 fields · synced May 30, 2026