Aldurazyme 2.9 Mg/5ml Medsu Vl1 Diag Us

FDA UDI

Class I (US FDA UDI)

by Genzyme Corp.

Identity

Trade Name: ALDURAZYME 2.9 MG/5ML MEDSU VL1 DIAG US FDA UDI
Generic Name: Assay development analyte-specific reagent IVD FDA UDI
Device Name: ALDURAZYME 2.9 MG/5ML MEDSU VL1 DIAG US FDA UDI
Model / Reference: 762618 FDA UDI
Description: ALDURAZYME 2.9 MG/5ML MEDSU VL1 DIAG US FDA UDI

Identifiers

Primary DI / UDI-DI: 00358468000019 FDA UDI
FDA Product Code: MVU FDA UDI
GMDN Term: Assay development analyte-specific reagent IVD FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 864.4020 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Assay development analyte-specific reagent IVD

The ALDURAZYME 2.9 MG/5ML MEDSU VL1 DIAG US device is a specific antibody-based analyte-specific reagent for the development of laboratory-developed tests (LDTs) or commercial in vitro diagnostic medical devices (IVDs). It is not labelled with instructions for use, diagnostic claims, or performance information. As an assay development analyte-specific reagent IVD, it is used to identify or quantify chemicals in biological specimens.

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Also classified as Assay development analyte-specific reagent IVD.

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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: Genzyme Corp.

Sources (1)

FDA UDI c4c090de-d4f6-4eb5-9485-fa143125f06b 33 fields · synced Jul 19, 2026