CAPILLARYS HEMOGLOBIN 2007

GUDID 03607360020074

Device that detects and measure hemoglobin variants using capillary electrophoresis

SEBIA

Multiple haemoglobin subtype IVD, kit, electrophoresis Multiple haemoglobin subtype IVD, kit, electrophoresis Multiple haemoglobin subtype IVD, kit, electrophoresis Multiple haemoglobin subtype IVD, kit, electrophoresis Multiple haemoglobin subtype IVD, kit, electrophoresis Multiple haemoglobin subtype IVD, kit, electrophoresis

• Primary Device ID: 03607360020074
• NIH Device Record Key: 3930d8a4-c7fc-411c-b876-99b818e8d9b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CAPILLARYS HEMOGLOBIN
• Version Model Number: 2007
• Catalog Number: 2007
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03607360020074 [Primary]

FDA Product Code

• GKA: Abnormal Hemoglobin Quantitation

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2022-06-10
• Device Publish Date: 2018-01-24

Devices Manufactured by SEBIA

• 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