Processor for use in preparation of cell blocks from cellular material and tissue fragments in PreservCyt®.

Processor for use in preparation of cell blocks from cellular material and tissue fragments in PreservCyt®.
Cellient® - Cellient Processor

Device Description

An electrically-powered automated or semi-automated laboratory instrument intended to be used for the processing of clinical tissue specimens [e.g., fixation (encapsulation in paraffin wax), dehydration, infiltration] in preparation for subsequent cytological or histological examination. The device may be a single unit or modular assembly.

Environmental Conditions

Handling Environment Humidity - Percent (%) Relative Humidity

80.00
20.00

Handling Environment Temperature - Degrees Celsius

32.00
16.00

Storage Environment Humidity - Percent (%) Relative Humidity

95.00
15.00

Storage Environment Temperature - Degrees Celsius

50.00
-28.00

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: IDT

Device Name: Apparatus, Melting Point, Paraffin

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: 864.3010

Third Party Flag: N

Medical Specialty: PA

Device Identifiers

Device Id: 15420045508569

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