ADVIA®120/2120/2120i OPTIpoint™

ADVIA®120/2120/2120i OPTIpoint™
ADVIA 120/2120/2120i® OPTIpoint - 10312283

Device Description

A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative determination of one or 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.

Environmental Conditions

Handling Environment Temperature - Degrees Celsius

8.00
2.00

Special Storage Condition, Specify

Protect from freezing

Storage Environment Temperature - Degrees Celsius

8.00
2.00

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: GKL

Device Name: Counter, Cell, Automated (Particle Counter)

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

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: 864.5200

Third Party Flag: Y

Medical Specialty: HE

Device Identifiers

Device Id: 00630414224329

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