Oral Fluid Amphetamine Calibrator, Low Calibrator

FDA UDI

Class II (US FDA UDI)

by Lin-Zhi International, Inc.

Identity

Trade Name: Oral Fluid Amphetamine Calibrator, Low Calibrator FDA UDI
Generic Name: Amphetamine-specific IVD, calibrator FDA UDI
Device Name: 5 mL/bottle. Concentration: 20 ng/mL of Amphetamine. FDA UDI
Model / Reference: S0042b FDA UDI
Description: 5 mL/bottle. Concentration: 20 ng/mL of Amphetamine. FDA UDI

Identifiers

Catalog Number: S0042b FDA UDI
Primary DI / UDI-DI: B076S0042B0 FDA UDI
510(k) Number: K131653 FDA UDI
FDA Product Code: DLJ FDA UDI
GMDN Term: Amphetamine-specific 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Amphetamine-specific IVD, calibrator

Oral Fluid Amphetamine Calibrator, Low Calibrator by Lin-Zhi International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Amphetamine-specific IVD, calibrator.

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Pointe Ecstasy (MDMA) Calibrator (100 ng/mL) Low — POINTE SCIENTIFIC, INC. · Class II
Rapid ONE — American Bio Medica Corp. · Class I

Cleared under the same submission

K131653 also covers:

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 54197671-ec35-4fe3-b816-c31795229c1a 36 fields · synced Jun 9, 2026