The Para-Pak Systems provide standardized procedures for the routine collection, transportation, preservation and examination of stool specimens for intestinal parasites. Kit systems are designed for easy use by individuals not trained in microbiological procedures and afford an excellent means of minimizing the adverse effects of delay in specimen transport.

The Para
Para-Pak LV-PVA / 10% Formalin / Clean - 330184

A covered receptacle containing transport buffer solution or microbiological medium (e.g., Carey-Blair transport medium) intended to be used for the collection, preservation, and transport of a faecal specimen for in vitro diagnostic investigation. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: FMH

Device Name: Container, Specimen, Sterile

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: HO

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: 864.3250

Third Party Flag: N

Medical Specialty: PA

Code: IGG

Device Name: Formaldehyde (Formalin, Formol)

Device Class: 1

Physical State: N/A

Definition: N/A

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: N/A

Regulation Number: 864.4010

Third Party Flag: N

Medical Specialty: PA

Code: IFQ

Device Name: Formulations, Mercuric Chloride For Tissue

Device Class: 1

Physical State: N/A

Definition: N/A

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: N/A

Regulation Number: 864.4010

Third Party Flag: N

Medical Specialty: PA

Device Id: 00840733103070

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