Cystine Lactose Electrolyte Deficient (CLED) Agar

FDA UDI

Class I (US FDA UDI)

by Neogen Corporation

Identity

Trade Name: Cystine Lactose Electrolyte Deficient (CLED) Agar FDA UDI
Generic Name: Differential/selective agar culture medium IVD FDA UDI
Device Name: Cystine Lactose Electrolyte Deficient (CLED) Agar is used for the differentiation and enumeration of microorganisms in urine. FDA UDI
Model / Reference: 2 FDA UDI
Description: Cystine Lactose Electrolyte Deficient (CLED) Agar is used for the differentiation and enumeration of microorganisms in urine. FDA UDI

Identifiers

Catalog Number: NCM0034D FDA UDI
Primary DI / UDI-DI: 00860003684672 FDA UDI
FDA Product Code: JSH FDA UDI
GMDN Term: Differential/selective agar culture medium IVD FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 866.2320 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

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

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Differential/selective agar culture medium IVD

Cystine Lactose Electrolyte Deficient (CLED) Agar by Neogen Corporation — 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: Neogen Corporation

Sources (1)

FDA UDI e6004a39-0527-4b6f-9849-7cf486fe44bd 36 fields · synced Jun 6, 2026