cobas&#x00AE Sample Prep Buffer

FDA UDI

Class I (US FDA UDI)

by Roche Molecular Systems, Inc.

Identity

Trade Name: cobas&#x00AE Sample Prep Buffer FDA UDI
Generic Name: Buffered wash solution IVD FDA UDI
Model / Reference: 08261580190 FDA UDI

Identifiers

Catalog Number: 08261580190 FDA UDI
Primary DI / UDI-DI: 00875197006223 FDA UDI
FDA Product Code: PPM FDA UDI
GMDN Term: Buffered wash solution 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 wash solution IVD

cobas&#x00AE Sample Prep Buffer by Roche Molecular Systems, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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TBS Auto Wash Buffer 20X — BIOCARE MEDICAL, LLC · Class I
ADVIA Centaur® PW 4 — Siemens Healthcare Diagnostics · Class I
ISE Buffer Reagent — DIAMOND DIAGNOSTICS Inc
ADVIA Centaur® Wash 1 — Siemens Healthcare Diagnostics · Class I

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: Roche Molecular Systems, Inc.

Sources (1)

FDA UDI 38379438-979a-4e8f-a95c-f086dd39da12 33 fields · synced Jun 9, 2026