Micro-Albumin ELISA is a competitive test system for the quantitative measurement of human albumin in urine.

Micro
Micro-Albumin ELISA - EIA-3881

Device Description

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of microalbumin in a clinical specimen, using a spectrophotometry method.

Environmental Conditions

No Data Available

Device Sizes

Calibrators

Enzyme Conjugate

Total Volume: 0.5 Milliliter

Stop Solution

Wash Buffer

Controls +/-

TMB Substrate

Total Volume: 20 Milliliter

Total Volume: 15 Milliliter

Sample Diluent

Calibrators
Enzyme Conjugate
Total Volume: 0.5 Milliliter
Stop Solution
Wash Buffer
Controls +/-
TMB Substrate
Total Volume: 20 Milliliter
Total Volume: 15 Milliliter
Sample Diluent

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: JIR

Device Name: Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: CH

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: 862.1645

Third Party Flag: N

Medical Specialty: CH

Device Identifiers

Device Id: 00840239038814

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