Imidazole Buffer Solution

FDA UDI

Class I (US FDA UDI)

by Siemens Healthcare Diagnostics Products Ltd

Identity

Trade Name: Imidazole Buffer Solution FDA UDI
Generic Name: Buffered sample diluent IVD FDA UDI
Device Name: Imidazole Buffer Solution is used as diluent for various coagulation assays FDA UDI
Model / Reference: 10446032 FDA UDI
Description: Imidazole Buffer Solution is used as diluent for various coagulation assays FDA UDI

Identifiers

Catalog Number: OQAA33 FDA UDI
Primary DI / UDI-DI: 00842768007163 FDA UDI
FDA Product Code: JCC FDA UDI
GMDN Term: Buffered sample diluent IVD FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 864.4010 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Buffered sample diluent IVD

Imidazole Buffer Solution by Siemens Healthcare Diagnostics Products Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Dimension® Purified Water Diluent — Siemens Healthcare Diagnostics · Class I
ADVIA Centaur® VitD Diluent Bottle — Siemens Healthcare Diagnostics · Class II
ARCHITECT — Abbott Laboratories, Inc. · Class II

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 I	Pending data

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Manufacturer

Manufacturer: Siemens Healthcare Diagnostics Products Ltd

Sources (1)

FDA UDI ab127a95-28f2-43fb-899a-44e974c3264e 36 fields · synced May 30, 2026