Toxicology Reagent Immunalysis Tapentadol CLIA Non-Waived For Automated Chemistry Analyzers

Name: Toxicology Reagent
Brand: Immunalysis

REAGENT KIT, TAPENTADOL HEIA 500ML (2/KT) D/S

McKesson #

1285847

Manufacturer #

343UR-0500

Brand

Immunalysis

Manufacturer

Abbott Rapid Immunalysis

Country of Origin

United States

Application

Toxicology Reagent

Buy American Act (BAA) Compliant

CLIA Classification

CLIA Non-Waived

CLIA Classified

CLIA Non-Waived

Container Type

Bottle

For Use With

For Automated Chemistry Analyzers

Form

Ready-to-Use Liquid

Product Dating

McKesson Acceptable Dating: we will ship >= 90 days

Storage Requirements

Requires Refrigeration

Test Method

Homogeneous Enzyme Immunoassay (HEIA)

Test Name

Tapentadol

Test Type

Single Drug

Trade Agreement Act (TAA) Compliant

Volume

RA: 1 X 500 mL, RE: 1 X 350 mL

The Immunalysis Tapentadol Urine HEIA™ is a homogeneous enzyme immunoassay (HEIA™) with a cutoff of 200 ng/mL
The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of tapentadol in human urine with automated clinical chemistry analyzers
Antibody/Substrate Reagent (RA) - This contains recombinant antibodies to tapentadol (<0.5%), glucose-6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in Tris buffer with Sodium Azide as preservative
Enzyme Conjugate Reagent (RE) - This contains glucose-6-phosphate dehydrogenase (G6PDH) labeled with tapentadol (<0.5%) in Tris buffer with Sodium Azide as preservative
CLIA Moderate Complexity (AU) / CLIA High Complex (ImmTox)