100 test kit

100 test kit
Serodia TP-PA Kits - 234952

Device Description

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to Treponema pallidum in a clinical specimen, using an agglutination method. The assay is designed to detect infection with Treponema pallidum, the bacteria associated with syphilis.

Environmental Conditions

Handling Environment Temperature - Degrees Celsius

56.00
2.00

Storage Environment Temperature - Degrees Celsius

8.00
2.00

Device Sizes

100 tests per kit

100 tests per kit

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: GMT

Device Name: Antigens, Ha, Treponema Pallidum

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: 866.3830

Third Party Flag: Y

Medical Specialty: MI

Device Identifiers

Device Id: 00869164000055

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