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Pointe Opiates 300 Reagent Set

FDA UDI

Class II (US FDA UDI)

by Pointe Scientific, Inc.

Identity

Trade Name
Pointe Opiates 300 Reagent Set FDA UDI
Generic Name
Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
Pointe Opiates 300 Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Opiates 300 Reagent Set is intended for the qualitative and semi-quantitative determination of opiates in human urine at a cutoff value of 300 ng/mL when calibrated against morphine. The assay is designed for prescription use with a number of automated clinical chemistry analyzers. This assay is for prescription use only. FDA UDI
Model / Reference
60-OP0040-1L FDA UDI
Description
Pointe Opiates 300 Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Opiates 300 Reagent Set is intended for the qualitative and semi-quantitative determination of opiates in human urine at a cutoff value of 300 ng/mL when calibrated against morphine. The assay is designed for prescription use with a number of automated clinical chemistry analyzers. This assay is for prescription use only. FDA UDI

Identifiers

Catalog Number
60-OP0040-1L FDA UDI
Primary DI / UDI-DI
00811727016874 FDA UDI
510(k) Number
K110298 FDA UDI
FDA Product Code
DJG FDA UDI
GMDN Term
Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3650 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA)

The Pointe Opiates 300 Reagent Set is a comprehensive collection of reagents and other associated materials designed for the qualitative and semi-quantitative determination of opiates in human urine. This enzyme immunoassay (EIA) method is intended for prescription use with automated clinical chemistry analyzers, ensuring accurate and reliable results. By using the Pointe Opiates 300 Reagent Set, healthcare professionals can ensure their patients receive timely and effective treatment.

Similar devices

Also classified as Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA).

Cleared under the same submission

K110298 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Pointe Scientific, Inc.

Sources (1)

  • FDA UDI 27df7560-3146-4682-bb98-42886a4ea9f9 37 fields · synced Aug 3, 2026