- Physicians Office Resource

Differential Counter 8 place
McKesson - 606

Device Description

A non-powered device intended to be used by a healthcare professional to manually record and display haematological cell counts of white blood cell populations in a clinical specimen, as observed under a microscope. It consists of multiple mechanical tally counters with a lever representing each white blood cell type (e.g., basophil, eosinophil, lympocyte) which the operator depresses to record an observed cell type. Totals for population counts are displayed on the device and used to subsequently calculate the percentages for each population.

Environmental Conditions

No Data Available

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: GKM

Device Name: Hand-Tally, Differential

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: HE

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: 864.6160

Third Party Flag: N

Medical Specialty: HE

Device Identifiers

Device Id: 40612479200140

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

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