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Methadone Metabolite 100 Qualitative Calibrator Set

FDA UDI

Class II (US FDA UDI)

by Lin-Zhi International, Inc.

Identity

Trade Name
Methadone Metabolite 100 Qualitative Calibrator Set FDA UDI
Generic Name
2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, calibrator FDA UDI
Device Name
EDDP 100 Cutoff Calibrator 100 ng/mL (1 x 5 mL). FDA UDI
Model / Reference
08735590190 FDA UDI
Description
EDDP 100 Cutoff Calibrator 100 ng/mL (1 x 5 mL). FDA UDI

Identifiers

Catalog Number
08735590190 FDA UDI
Primary DI / UDI-DI
00850624008186 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 100 Qualitative Calibrator Set by Lin-Zhi International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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 4d169c5c-6f23-408f-bba6-f671416a0ff7 35 fields · synced Jun 9, 2026