CAPILLARYS NEONAT Hb 2006

GUDID 03607360020067

Device used to detect hemoglobin variants using dry blood spots on 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: 03607360020067
• NIH Device Record Key: 30640654-eb6b-4a78-a6c5-47db79d436a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CAPILLARYS NEONAT Hb
• Version Model Number: 2006
• Catalog Number: 2006
• 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: false
• 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	03607360020067 [Primary]

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

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• 03607360020296 - CAPILLARYS CDT MAXI KIT: 2023-09-13 CARBOHYDRATE DEF TRANSFERRIN BY CE MAXI KIT
• 03607360022085 - MINICAP CDT: 2023-09-13 CARBOHYDRATE DEF TRANSFERRIN BY MINICAP CE
• 03607360022283 - MINICAP CDT MAXI KIT: 2023-09-13 CARBOHYDRATE DEF TRANSFERRIN BY CE MINICAP
• 03607360025093 - CAPI 3 CDT: 2023-09-13 CARBOHYDRATE DEF TRANSFERRIN BY CE
• 03607360047583 - Hb AFSA2 CONTROL (1): 2023-08-04