Kallestad HEp-2 Cell Line Substrate

Kallestad HEp
Kallestad - 32583

Device Description

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening for one or multiple antinuclear antibodies (ANA) in a clinical specimen, using a fluorescent immunoassay method.

Environmental Conditions

Special Storage Condition, Specify

Please see kit labeling for individual component temperature controls

Device Sizes

6 Well

48 Tests

6 Well
48 Tests

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: DBM

Device Name: Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: IM

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: 866.5090

Third Party Flag: Y

Medical Specialty: IM

Device Identifiers

Device Id: 00847865001588

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