INSTRUMENT

INSTRUMENT
CAPILLARYS 3 DBS - 1244

Device Description

An electrically-powered automated or semi-automated laboratory instrument or system intended to be used for the qualitative and/or quantitative in vitro determination of various molecules (e.g., DNA, RNA, proteins) in a clinical specimen based on their size, ionic charge and/or rate of migration through an electrically charged field.

Environmental Conditions

Special Storage Condition, Specify

Avoid contact with water_Dangerous Voltage_Do not store near magnets or magnetic devices_Fragile handle with care_Keep away from sunlight_This way up

Storage Environment Humidity - Percent (%) Relative Humidity

80.00
5.00

Storage Environment Temperature - Degrees Celsius

30.00
15.00

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: GKA

Device Name: Abnormal Hemoglobin Quantitation

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: 864.7415

Third Party Flag: Y

Medical Specialty: HE

Device Identifiers

Device Id: 03607360012444

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