Pointe Cocaine Level 2 Control (BE 375 ng/mL)

FDA UDI

Class I (US FDA UDI)

by Pointe Scientific, Inc.

Identity

Trade Name: Pointe Cocaine Level 2 Control (BE 375 ng/mL) FDA UDI
Generic Name: Cocaine/cocaine metabolite IVD, control FDA UDI
Device Name: Pointe Cocaine Level 2 Control (BE 375 ng/mL) 1 x 5 mL The Pointe Cocaine Metabolite Controls are for use as assayed quality control materials to monitor the precision of the Pointe Cocaine Metabolite Reagent Set (Ref# 60-CC0060-100/60-CC0060-1L) on a number of automated clinical chemistry analyzers. FDA UDI
Model / Reference: 60-CC0076-5 FDA UDI
Description: Pointe Cocaine Level 2 Control (BE 375 ng/mL) 1 x 5 mL The Pointe Cocaine Metabolite Controls are for use as assayed quality control materials to monitor the precision of the Pointe Cocaine Metabolite Reagent Set (Ref# 60-CC0060-100/60-CC0060-1L) on a number of automated clinical chemistry analyzers. FDA UDI

Identifiers

Catalog Number: 60-CC0076-5 FDA UDI
Primary DI / UDI-DI: 00811727017826 FDA UDI
510(k) Number: K020769 FDA UDI
FDA Product Code: LAS FDA UDI
GMDN Term: Cocaine/cocaine metabolite 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Cocaine/cocaine metabolite IVD, control

Pointe Cocaine Level 2 Control (BE 375 ng/mL) by Pointe Scientific, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Cocaine/cocaine metabolite IVD, control.

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Cleared under the same submission

K020769 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 I	Pending data

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Manufacturer

Manufacturer: Pointe Scientific, Inc.

Sources (1)

FDA UDI 16a00684-1aba-4619-a411-2f0d065bed59 37 fields · synced May 31, 2026