Barbiturate DAU Calibrator, Calibrator #5

FDA UDI

Class II (US FDA UDI)

by Lin-Zhi International, Inc.

Identity

Trade Name: Barbiturate DAU Calibrator, Calibrator #5 FDA UDI
Generic Name: Barbiturate IVD, calibrator FDA UDI
Device Name: 5mL/bottle. Concentration: 1000 ng/mL of Secobarbital. FDA UDI
Model / Reference: 0145 FDA UDI
Description: 5mL/bottle. Concentration: 1000 ng/mL of Secobarbital. FDA UDI

Identifiers

Catalog Number: 0145 FDA UDI
Primary DI / UDI-DI: B07601450 FDA UDI
510(k) Number: K032764 FDA UDI
FDA Product Code: DLJ FDA UDI
GMDN Term: Barbiturate 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: Barbiturate IVD, calibrator

Barbiturate DAU Calibrator, Calibrator #5 by Lin-Zhi International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Barbiturate IVD, calibrator.

Pointe Barbiturate Calibrator/Control (Secobarbital 200 ng/mL) — POINTE SCIENTIFIC, INC. · Class II
Pointe Barbiturate Calibrator/Control (Secobarbital 100 ng/mL) — POINTE SCIENTIFIC, INC. · Class II
Rapid TOX — American Bio Medica Corp. · U
Pointe Barbiturate Calibrator/Control (Secobarbital 300 ng/mL) — POINTE SCIENTIFIC, INC. · Class II
Pointe Barbiturate Calibrator (Secobarbital 1000 ng/mL) — POINTE SCIENTIFIC, INC. · Class II
Barbiturate DAU Calibrator/Control, Calibrator #4/Cutoff B/Control 3 — Lin-Zhi International, Inc. · Class I
Barbiturate DAU Calibrator/Control, Calibrator #2/Control 1 — Lin-Zhi International, Inc. · Class I
Barbiturate DAU Calibrator/Control, Calibrator #3/Cutoff A/Control 2 — Lin-Zhi International, Inc. · Class I

Cleared under the same submission

K032764 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 f07c682d-6f66-4040-9252-1ef5995ca138 36 fields · synced Jun 9, 2026