The Aptima® Auto Detect Kit. This kit is to be used with the Leader® HC+ Luminometer and the Tigris® instrument system.

The Aptima® Auto Detect Kit. This kit is to be used with the Leader® HC+ Luminometer and the Tigris® instrument system.
Aptima® - APTIMA AUTO DETECT KIT (CE)

A collection of reagents and other associated materials intended to be used to generate a chemiluminescent signal when performing an assay using a nucleic acid technique (NAT) on a clinical specimen. The kit is typically used in conjunction with luminescent-labelled nucleic acid oligonucleotide probes of known sequences and may also include reference material to optimise and verify performance of the luminometer instrument.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: LSL

Device Name: Dna-Reagents, Neisseria

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: 866.3390

Third Party Flag: N

Medical Specialty: MI

Code: MKZ

Device Name: Dna Probe, Nucleic Acid Amplification, Chlamydia

Device Class: 1

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: 866.3120

Third Party Flag: Y

Medical Specialty: MI

Device Id: 15420045500259

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