Pointe Methamphetamine Calibrator (2000 ng/mL) High

FDA UDI

Class II (US FDA UDI)

by Pointe Scientific, Inc.

Identity

Trade Name: Pointe Methamphetamine Calibrator (2000 ng/mL) High FDA UDI
Generic Name: Methamphetamine-specific IVD, calibrator FDA UDI
Device Name: Pointe Methamphetamine Calibrator (2000 ng/mL) High 1 x 5 mL The Pointe Methamphetamine Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the Pointe Methamphetamine Reagent Set (Ref# 60-MP0700-100/60-MP0700-1L) on a number of automated clinical chemistry analyzers. FDA UDI
Model / Reference: 60-MP0710-5 FDA UDI
Description: Pointe Methamphetamine Calibrator (2000 ng/mL) High 1 x 5 mL The Pointe Methamphetamine Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the Pointe Methamphetamine Reagent Set (Ref# 60-MP0700-100/60-MP0700-1L) on a number of automated clinical chemistry analyzers. FDA UDI

Identifiers

Catalog Number: 60-MP0710-5 FDA UDI
Primary DI / UDI-DI: 00811727018359 FDA UDI
510(k) Number: K113661 FDA UDI
FDA Product Code: DLJ FDA UDI
GMDN Term: Methamphetamine-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: Methamphetamine-specific IVD, calibrator

Pointe Methamphetamine Calibrator (2000 ng/mL) High by Pointe Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K113661 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 65cac821-bcd3-48bb-b645-7b481a977ab2 37 fields · synced Jun 8, 2026