CAPILLARYS 3 DBS 1244

GUDID 03607360012444

INSTRUMENT

SEBIA

Electrophoresis analyser IVD

• Primary Device ID: 03607360012444
• NIH Device Record Key: bbbcf99b-b3f4-4c07-a981-91581e5f23aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CAPILLARYS 3 DBS
• Version Model Number: 1244
• Catalog Number: 1244
• Company DUNS: 276801933
• Company Name: SEBIA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *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 Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *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 Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *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 Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *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 Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *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 Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *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 Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *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 Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *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 Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *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 Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *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 Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *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 Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *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 Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *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 Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *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 Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *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 Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03607360012444 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232027

FDA Product Code

• GKA: Abnormal Hemoglobin Quantitation

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-08
• Device Publish Date: 2024-04-30

Devices Manufactured by SEBIA

• 03607360012444 - CAPILLARYS 3 DBS: 2024-05-08INSTRUMENT
• 03607360012444 - CAPILLARYS 3 DBS: 2024-05-08 INSTRUMENT
• 03607360025062 - CAPI 3 NEONAT Hb: 2024-05-08
• 03607360025635 - CAPI 3 NEONAT HEMOLYSING SOLUTION: 2024-05-08
• 03607360025789 - CAPILLARYS 3 DBS MICROPLATES: 2024-05-08 MICROPLATES ARE AN ACCESSORY _PLASTIC PLATES
• 03607360047576 - CAPI 3 NEONAT Hb AF Control: 2024-05-08
• 03607360047927 - Hb AFSC Control: 2024-05-08
• 03607360026014 - ANTISERA CAPI 3 IT (10): 2023-12-07
• 03607360026021 - Sample Diluent CAPI 3 IT (10): 2023-12-07