← Back to catalogue

LysoPC IS

FDA UDI

Class I (US FDA UDI)

by Wallac, Inc.

Identity

Trade Name
LysoPC IS FDA UDI
Generic Name
Assay development analyte-specific reagent IVD FDA UDI
Device Name
N/A FDA UDI
Model / Reference
4417-0010 FDA UDI
Description
N/A FDA UDI

Identifiers

Catalog Number
4417-0010 FDA UDI
Primary DI / UDI-DI
06438147392339 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

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

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Assay development analyte-specific reagent IVD

LysoPC IS by Wallac, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Assay development analyte-specific reagent IVD.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Wallac, Inc.

Sources (1)

  • FDA UDI a43f7db5-49e4-4489-9ad8-969a61b825a7 35 fields · synced May 31, 2026