YSI Incorporated

FDA UDI

Class II (US FDA UDI)

by Ysi Incorporated

Identity

Trade Name: YSI Incorporated FDA UDI
Generic Name: Lactate IVD, reagent FDA UDI
Device Name: 2329 LACTATE MEMBRANE KIT FDA UDI
Model / Reference: 2329 FDA UDI
Description: 2329 LACTATE MEMBRANE KIT FDA UDI

Identifiers

Catalog Number: 065034 FDA UDI
Primary DI / UDI-DI: 00851683007172 FDA UDI
FDA Product Code: CGA FDA UDI
GMDN Term: Lactate IVD, reagent FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1345 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

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Lactate IVD, reagent

YSI Incorporated by Ysi Incorporated — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Ysi Incorporated

Sources (1)

FDA UDI 2b71a316-e57a-4ebb-b122-00118b8694b3 34 fields · synced Jun 1, 2026