N Predilution Wells

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics Products Ltd

Identity

Trade Name: N Predilution Wells FDA UDI
Generic Name: Assay container IVD, single-use FDA UDI
Device Name: The N Predilution Well is used for settings of dilutions of standards, controls and sera. FDA UDI
Model / Reference: 10446521 FDA UDI
Description: The N Predilution Well is used for settings of dilutions of standards, controls and sera. FDA UDI

Identifiers

Catalog Number: OVIC11 FDA UDI
Primary DI / UDI-DI: 00842768012174 FDA UDI
510(k) Number: K943997 FDA UDI
FDA Product Code: DEW FDA UDI
GMDN Term: Assay container IVD, single-use 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Assay container IVD, single-use

N Predilution Wells by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K943997 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Siemens Healthcare Diagnostics Products Ltd

Sources (1)

FDA UDI f346df64-b9d6-4604-8c68-6606d81e745e 36 fields · synced Jun 8, 2026