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Carolina Liquid Chemistries Methadone Metabolite EDDP

FDA UDI

Class II (US FDA UDI)

by Carolina Liquid Chemistries Corp.

Identity

Trade Name
Carolina Liquid Chemistries Methadone Metabolite EDDP FDA UDI
Generic Name
2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
Methadone Metabolite Enzyme Immunoassay FDA UDI
Model / Reference
AU-426B FDA UDI
Description
Methadone Metabolite Enzyme Immunoassay FDA UDI

Identifiers

Catalog Number
AU-426B FDA UDI
Primary DI / UDI-DI
00817302022926 FDA UDI
FDA Product Code
DJR FDA UDI
GMDN Term
2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3620 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Total Volume — 60 Milliliter FDA UDI
Total Volume — 23 Milliliter FDA UDI

Category: 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, kit, enzyme immunoassay (EIA)

Carolina Liquid Chemistries Methadone Metabolite EDDP by Carolina Liquid Chemistries Corp. — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, kit, enzyme immunoassay (EIA).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Carolina Liquid Chemistries Corp.

Sources (1)

  • FDA UDI 7d85d3bb-6474-4f9c-bac8-c7837785f828 37 fields · synced May 30, 2026