Pointe Multi-Analyte E DAU Level 1 Control

FDA UDI

Class I (US FDA UDI)

by Pointe Scientific, Inc.

Identity

Trade Name: Pointe Multi-Analyte E DAU Level 1 Control FDA UDI
Generic Name: Multiple drugs of abuse IVD, control FDA UDI
Device Name: Pointe Multi-Analyte E DAU Level 1 Control 1 x 15 mL The Pointe Multi-Analyte Set E Controls are for use as controls in the qualitative and semi-quantitative calibration of drugs of abuse enzyme immunoassays for the detection of secobarbital, norbuprenorphine, methadone, and phencyclidine in human urine on anumber of automated clinical chemistry analyzers. FDA UDI
Model / Reference: 60-MA1794-15 FDA UDI
Description: Pointe Multi-Analyte E DAU Level 1 Control 1 x 15 mL The Pointe Multi-Analyte Set E Controls are for use as controls in the qualitative and semi-quantitative calibration of drugs of abuse enzyme immunoassays for the detection of secobarbital, norbuprenorphine, methadone, and phencyclidine in human urine on anumber of automated clinical chemistry analyzers. FDA UDI

Identifiers

Catalog Number: 60-MA1794-15 FDA UDI
Primary DI / UDI-DI: 00811727017734 FDA UDI
FDA Product Code: DIF FDA UDI
GMDN Term: Multiple drugs of abuse IVD, control FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.3280 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Multiple drugs of abuse IVD, control

Pointe Multi-Analyte E DAU Level 1 Control by Pointe Scientific, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 I	Pending data

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Manufacturer

Manufacturer: Pointe Scientific, Inc.

Sources (1)

FDA UDI 158a4145-148f-4d4a-9384-ef47662676a9 36 fields · synced Jun 8, 2026