Carolina Liquid Chemistries Corp. Fentanyl Enzyme Immunoassay (FENT) DT428

FDA UDI

Class II (US FDA UDI)

by Carolina Liquid Chemistries Corp.

Identity

Trade Name: Carolina Liquid Chemistries Corp. Fentanyl Enzyme Immunoassay (FENT) DT428 FDA UDI
Generic Name: Fentanyl IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name: Fentanyl Enzyme Immunoassay FDA UDI
Model / Reference: DT428 FDA UDI
Description: Fentanyl Enzyme Immunoassay FDA UDI

Identifiers

Catalog Number: DT428 FDA UDI
Primary DI / UDI-DI: 00817302022292 FDA UDI
FDA Product Code: DJG FDA UDI
GMDN Term: Fentanyl IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.3650 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

Yes

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

Dimensions & Sizes

Size: Total Volume — 30 Milliliter FDA UDI
Total Volume — 10 Milliliter FDA UDI

Category: Fentanyl IVD, kit, enzyme immunoassay (EIA)

Carolina Liquid Chemistries Corp. Fentanyl Enzyme Immunoassay (FENT) DT428 by Carolina Liquid Chemistries Corp. — Class II — FDA UDI — listed in FDA GUDID

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Also classified as Fentanyl IVD, kit, enzyme immunoassay (EIA).

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LZI Fentanyl (Q) Enzyme Immunoassay — Lin-Zhi International, Inc. · Class II
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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: Carolina Liquid Chemistries Corp.

Sources (1)

FDA UDI fc318dd7-acb8-4f31-a6ce-52f85514ac27 37 fields · synced Jun 8, 2026