Aptima® General Purpose Reagents, 250 test, box 2 of 2 (2°C to 8°C box). The Aptima® General Purpose Reagents (GPRs) feature Transcription-Mediated Amplification (TMA®) and Hybridization Protection Assay (HPA) technologies. Aptima® GPRs may be used to facilitate the development of tests by CLIA-certified high complexity laboratories or research laboratories for the qualitative detection of nucleic acid-based analytes.

Aptima® General Purpose Reagents, 250 test, box 2 of 2 (2°C to 8°C box). The Aptima® General Purpose Reagents (GPRs) feature Transcription
Aptima® - APTIMA GPRS, 250 TESTS (REF)

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple types of microorganisms associated with sexually transmitted infections (STI), in a clinical specimen, using a nucleic acid technique (NAT). Microorganisms detected may include (but are not limited to) Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma species, Ureaplasma species, Treponema pallidum, Trichomonas vaginalis, herpes simplex virus 1 and/or herpes simplex virus 2 (HSV1 & 2).

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: PPM

Device Name: General Purpose Reagent

Device Class: 1

Physical State: N/A

Definition: A general purpose reagent is a chemical reagent that has general laboratory application, that is used to collect, prepare, and examine specimens from the human body for diagnostic purposes, and that is not labeled or otherwise intended for a specific diagnostic application. It may be either an individual substance, or multiple substances reformulated, which, when combined with or used in conjunction with an appropriate analyte specific reagent (ASR) and other general purpose reagents, is part of a diagnostic test procedure or system constituting a finished in vitro diagnostic (IVD) test.

Submission Type ID: 4

Review Panel: PA

Review Code: N/A

Technical Method: Y

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Diagnostic

Regulation Number: 864.4010

Third Party Flag: N

Medical Specialty: PA

Device Id: 15420045506442

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