HAV total QC kit - CENTAUR - CTL

HAV total QC kit
ADVIA Centaur® aHAVT QC - 10309005

Device Description

A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of total antibodies to the Hepatitis A virus in a clinical specimen.

Environmental Conditions

Special Storage Condition, Specify

Store Upright, Protect from Light, Do not freeze, Resuspend.

Storage Environment Temperature - Degrees Celsius

8.00
2.00

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: LOL

Device Name: Hepatitis A Test (Antibody And Igm Antibody)

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

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: 866.3310

Third Party Flag: N

Medical Specialty: MI

Device Identifiers

Device Id: 00630414509259

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

HAV total QC kit - CENTAUR - CTL - 2x2x7mL