- Physicians Office Resource

WRP CHECK
WRP CHECK - BG234784

Device Description

A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of multiple whole blood cell parameters in a clinical specimen [also known as complete blood count (CBC)]. Test components may include white cell count and differential, red cell count, and calculation of red cell parameters and/or platelet count, as well as other general blood evaluation tests [e.g., C-reactive protein (CRP)].

Environmental Conditions

Storage Environment Temperature - Degrees Celsius

8.00
2.00

Device Sizes

Total Volume: 2 Milliliter

Total Volume: 2 Milliliter

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: JPK

Device Name: Mixture, Hematology Quality Control

Device Class: 2

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: 864.8625

Third Party Flag: N

Medical Specialty: HE

Device Identifiers

Device Id: 14987562461780

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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