Pointe Methadone Reagent Set

FDA UDI

Class II (US FDA UDI)

by Pointe Scientific, Inc.

Identity

Trade Name: Pointe Methadone Reagent Set FDA UDI
Generic Name: Methadone IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name: Pointe Methadone Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Methadone Reagent Set is intended for the qualitative and semi-quantitative determination of methadone in human urine at a cutoff value of 300 ng/mL. The assay is designed for prescription use with a number of automated clinical chemistry analyzers. FDA UDI
Model / Reference: 60-ME0220-1L FDA UDI
Description: Pointe Methadone Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Methadone Reagent Set is intended for the qualitative and semi-quantitative determination of methadone in human urine at a cutoff value of 300 ng/mL. The assay is designed for prescription use with a number of automated clinical chemistry analyzers. FDA UDI

Identifiers

Catalog Number: 60-ME0220-1L FDA UDI
Primary DI / UDI-DI: 00811727017031 FDA UDI
510(k) Number: K023317 FDA UDI
FDA Product Code: DJR FDA UDI
GMDN Term: Methadone IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.3620 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: Methadone IVD, kit, enzyme immunoassay (EIA)

Pointe Methadone Reagent Set 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

K023317 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 37194c38-847f-41a4-bff5-87157dc8019c 37 fields · synced May 31, 2026