Aptima - Assay Fluids
Device Description
A collection of reagents and other associated materials intended to be used to optimise an assay performed using a nucleic acid technique (NAT) on a clinical specimen. The kit typically consists of a silicone oil to minimize evaporation, buffered solutions for washing steps and reaction stop reagents.
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: 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
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
Device IdentifiersDevice Id: 15420045500280
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