Multi-Analyte DAU Calibrator Set D, Intermediate Calibrator

FDA UDI

Class II (US FDA UDI)

by Lin-Zhi International, Inc.

Identity

Trade Name: Multi-Analyte DAU Calibrator Set D, Intermediate Calibrator FDA UDI
Generic Name: Multiple drugs of abuse IVD, calibrator FDA UDI
Device Name: 15 mL/bottle. Concentration of Multi-Analyte: 1000 ng/mL benzoylecgonine, 1500 ng/mL d-methamphetamine, 600 ng/mL morphine, 500 ng/mL oxazepam, and 300 ng/mL oxycodone. FDA UDI
Model / Reference: 0874 FDA UDI
Description: 15 mL/bottle. Concentration of Multi-Analyte: 1000 ng/mL benzoylecgonine, 1500 ng/mL d-methamphetamine, 600 ng/mL morphine, 500 ng/mL oxazepam, and 300 ng/mL oxycodone. FDA UDI

Identifiers

Catalog Number: 0874 FDA UDI
Primary DI / UDI-DI: B07608740 FDA UDI
FDA Product Code: DKB FDA UDI
GMDN Term: Multiple drugs of abuse 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

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

Yes

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Lot / Batch Number

Yes

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Serial Number

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Expiration Date

Yes

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Manufacturing Date

FDA UDI

Category: Multiple drugs of abuse IVD, calibrator

Multi-Analyte DAU Calibrator Set D, Intermediate Calibrator by Lin-Zhi International, Inc. — Class II — FDA UDI — listed in FDA GUDID

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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: Lin-Zhi International, Inc.

Sources (1)

FDA UDI 7585866b-0f46-4407-9a42-e4c3d6cf01c6 35 fields · synced Jun 9, 2026