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N Cuvette Segments for BN II

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics Products Ltd

Identity

Trade Name
N Cuvette Segments for BN II FDA UDI
Generic Name
Nephelometry immunoassay analyser IVD FDA UDI
Device Name
The N-cuvettessegment is an consumable in the BNII system. FDA UDI
Model / Reference
10446520 FDA UDI
Description
The N-cuvettessegment is an consumable in the BNII system. FDA UDI

Identifiers

Catalog Number
OVIB31 FDA UDI
Primary DI / UDI-DI
00842768012167 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Nephelometry immunoassay analyser IVD

N Cuvette Segments for BN II 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 19aa22c2-7673-4225-b00c-ca1d82736de4 36 fields · synced Jun 8, 2026