Roche MICROSAMPLER PROTECT

FDA UDI

Class I (US FDA UDI)

by Roche Diagnostics Corp.

Identity

Trade Name: Roche MICROSAMPLER PROTECT FDA UDI
Generic Name: Assay container IVD, single-use FDA UDI
Model / Reference: 05772591001 FDA UDI

Identifiers

Catalog Number: 05772591001 FDA UDI
Primary DI / UDI-DI: 04015630036684 FDA UDI
FDA Product Code: CBT FDA UDI
GMDN Term: Assay container IVD, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 868.1100 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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

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: Assay container IVD, single-use

Roche MICROSAMPLER PROTECT by Roche Diagnostics Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 Diagnostics Corp.

Sources (1)

FDA UDI 48173de5-c279-4860-a4ac-38eb4a82d728 33 fields · synced May 30, 2026