CytoLyt® Solution for use as a cell wash and transport buffer in collection cups.

CytoLyt® Solution for use as a cell wash and transport buffer in collection cups.
ThinPrep® - ThinPrep® CytoLyt® Sol'n 30-mL cup

A covered receptacle (single- or multiple-compartment) containing a tissue fixation or preservation solution [e.g., formalin, saline] intended to be used for the collection, and preservation and/or transport, of any type of tissue specimen (e.g., biopsy tissue) collected from any body part for in vitro diagnostic investigation. It does not contain patient-contact tissue specimen sampling/excision devices. This is a single-use device.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: LEA

Device Name: Preservative, Cytological

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: 15420045514614

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

Device Id: 25420045514611

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 15420045514614

Package Quantity: 50

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: BOX