Versatrek 240 W/4 Drawers/Ctrl Mod

FDA UDI

Class I (US FDA UDI)

by Remel, Inc.

Identity

Trade Name: VERSATREK 240 W/4 DRAWERS/CTRL MOD FDA UDI
Generic Name: Blood culture analyser IVD FDA UDI
Device Name: VERSATREK 240 W/4 DRAWERS/CTRL MOD FDA UDI
Model / Reference: Y24004 FDA UDI
Description: VERSATREK 240 W/4 DRAWERS/CTRL MOD FDA UDI

Identifiers

Primary DI / UDI-DI: 00848838096426 FDA UDI
FDA Product Code: MDB FDA UDI
GMDN Term: Blood culture analyser IVD FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 866.2560 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

Yes

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Blood culture analyser IVD

Versatrek 240 W/4 Drawers/Ctrl Mod by Remel, Inc. — 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: Remel, Inc.

Sources (1)

FDA UDI d0190203-a5ea-4464-b397-c0353be7c3be 33 fields · synced May 31, 2026