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BN II System

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics Products Ltd

Identity

Trade Name
BN II System FDA UDI
Generic Name
Nephelometry immunoassay analyser IVD FDA UDI
Device Name
The BN II is a system for the quantitative determination of proteins in serum, plasma, urine and CSF FDA UDI
Model / Reference
11254820 FDA UDI
Description
The BN II is a system for the quantitative determination of proteins in serum, plasma, urine and CSF FDA UDI

Identifiers

Catalog Number
OVIA112 FDA UDI
Primary DI / UDI-DI
00630414002903 FDA UDI
510(k) Number
K943997 FDA UDI
FDA Product Code
DEW FDA UDI
GMDN Term
Nephelometry immunoassay analyser IVD 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Nephelometry immunoassay analyser IVD

BN II System by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Nephelometry immunoassay analyser IVD.

Cleared under the same submission

K943997 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 163a51c9-4cfe-4570-a99e-6e766d67f46b 36 fields · synced May 30, 2026