IMMAGE Immunochemistry Systems DNB Antideoxyribonuclease-B Reagent


Product Overview

IMMAGE Immunochemistry Systems DNB Antideoxyribonuclease
IMMAGE - 447480


Device Description

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to DNAse B enzyme produced by Group A beta-haemolytic Streptococcus bacteria in a clinical specimen, using an enzyme immunoassay (EIA) method.


Environmental Conditions

No Data Available


Device Sizes

No Data Available


Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available


Product Codes

Code: GTR

Device Name: Antideoxyribonuclease, Streptococcus Spp.

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: MI

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: 866.3720

Third Party Flag: N

Medical Specialty: MI


Device Identifiers

Device Id: 15099590233242

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


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