Pointe Barbiturate Calibrator/Control (Secobarbital 200 ng/mL)

FDA UDI

Class II (US FDA UDI)

by Pointe Scientific, Inc.

Identity

Trade Name: Pointe Barbiturate Calibrator/Control (Secobarbital 200 ng/mL) FDA UDI
Generic Name: Barbiturate IVD, calibrator FDA UDI
Device Name: Pointe Barbiturate Calibrator/Control (Secobarbital 200 ng/mL) 1 x 5 mL The Pointe Barbiturate Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the Pointe Barbiturate Reagent Set (Ref# 60-BA0280-100/60-BA0280-1L) on a number of automated clinical chemistry analyzers. The Pointe Barbiturate Controls are for use as assayed quality control materials to monitor the precision of the Pointe Barbiturate Reagent Set (Ref# 60-BA0280-100/60-BA0280-1L) on a number of automated clinical chemistry analyzers. FDA UDI
Model / Reference: 60-BA0286-5 FDA UDI
Description: Pointe Barbiturate Calibrator/Control (Secobarbital 200 ng/mL) 1 x 5 mL The Pointe Barbiturate Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the Pointe Barbiturate Reagent Set (Ref# 60-BA0280-100/60-BA0280-1L) on a number of automated clinical chemistry analyzers. The Pointe Barbiturate Controls are for use as assayed quality control materials to monitor the precision of the Pointe Barbiturate Reagent Set (Ref# 60-BA0280-100/60-BA0280-1L) on a number of automated clinical chemistry analyzers. FDA UDI

Identifiers

Catalog Number: 60-BA0286-5 FDA UDI
Primary DI / UDI-DI: 00811727017208 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

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Manufacturing Date

FDA UDI

Category: Barbiturate IVD, calibrator

Pointe Barbiturate Calibrator/Control (Secobarbital 200 ng/mL) by Pointe Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Barbiturate IVD, calibrator.

Barbiturate DAU Calibrator, Calibrator #5 — Lin-Zhi International, Inc. · Class II
Rapid TOX — American Bio Medica Corp. · U
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
Pointe Barbiturate Calibrator/Control (Secobarbital 100 ng/mL) — POINTE SCIENTIFIC, INC. · Class II
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

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: Pointe Scientific, Inc.

Sources (1)

FDA UDI 6ad0c894-257c-4ed9-ba1b-c27f3700cfe0 37 fields · synced May 30, 2026