Pointe 6-Acetylmorphine Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe 6-Acetylmorphine Reagent Set is intended for the qualitative and semi-quantitative determination of 6-acetylmorphine in human urine at a cutoff value of 10 ng/mL. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.

Pointe 6
Pointe 6-Acetylmorphine Reagent Set - 60-AC0580-1L

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of 6-acetyl morphine in a clinical specimen, using an enzyme immunoassay (EIA) method.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: DJG

Device Name: Enzyme Immunoassay, Opiates

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: TX

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 862.3650

Third Party Flag: Y

Medical Specialty: TX

Device Id: 00811727018229

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A