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Methadone Metabolite 300 DAU Calibrator, Intermediate Calibrator

FDA UDI

Class II (US FDA UDI)

by Lin-Zhi International, Inc.

Identity

Trade Name
Methadone Metabolite 300 DAU Calibrator, Intermediate Calibrator FDA UDI
Generic Name
2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, calibrator FDA UDI
Device Name
5mL/bottle. Concentration: 600 ng/mL of EDDP. FDA UDI
Model / Reference
0194b FDA UDI
Description
5mL/bottle. Concentration: 600 ng/mL of EDDP. FDA UDI

Identifiers

Catalog Number
0194b FDA UDI
Primary DI / UDI-DI
B0760194B0 FDA UDI
FDA Product Code
DLJ FDA UDI
GMDN Term
2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, calibrator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3200 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

Category: 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, calibrator

Methadone Metabolite 300 DAU Calibrator, Intermediate Calibrator by Lin-Zhi International, Inc. — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, calibrator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Lin-Zhi International, Inc.

Sources (1)

  • FDA UDI 867a8620-8f15-47cc-88e4-dc771147e9e9 35 fields · synced Jun 9, 2026