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HPLC Cartridge (iHPLC)

FDA UDI

Class I (US FDA UDI)

by Roche Diagnostics Corp.

Identity

Trade Name
HPLC Cartridge (iHPLC) FDA UDI
Generic Name
High performance liquid chromatography analyser column IVD FDA UDI
Model / Reference
09511725190 FDA UDI

Identifiers

Catalog Number
09511725190 FDA UDI
Primary DI / UDI-DI
07613336228630 FDA UDI
FDA Product Code
DPM FDA UDI
GMDN Term
High performance liquid chromatography analyser column IVD FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.2260 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

Yes

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: High performance liquid chromatography analyser column IVD

HPLC Cartridge (iHPLC) by Roche Diagnostics Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as High performance liquid chromatography analyser column IVD.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Roche Diagnostics Corp.

Sources (1)

  • FDA UDI e88ceb3b-af8d-47f1-9139-a45667f4ce56 33 fields · synced Jun 6, 2026