Para-Pak Macro-CON is a system for the concentration of eggs, larvae, and protozoa from preserved fecal specimens. The filtration unit is designed to be used directly with the Para-Pak specimen collection vial. This creates a completely closed system, minimizing exposure of the user to potentially infectious agents. Macro-CON concentration utilizes the entire contents of the Para-Pak specimen collection vial, reducing variation due to specimen sampling. This is of particular advantage to the clinical parasitologist when a small number of organisms may be present in a large volume of stool.

Para
Para-Pak Macro-CON - 970120

A collection of reagents and other associated materials (e.g., filters, containers) intended to be used for the isolation and concentration of intestinal parasites [e.g., helminth eggs and larvae, protozoan trophozoites and cysts] from a faecal specimen, using one or a combination of techniques (e.g., centrifugation, filtration, organic solvent or surfactant treatment), for further in vitro diagnostic investigation. This is a single-use device.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: LKS

Device Name: Device, Parasite Concentration

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

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: 866.2900

Third Party Flag: N

Medical Specialty: MI

Device Id: 00840733102028

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