FLC Kappa 5102

GUDID 03607360051023

SEBIA

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• Primary Device ID: 03607360051023
• NIH Device Record Key: dbfaa4ff-fb1e-404a-817c-d9cd460ce660
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FLC Kappa
• Version Model Number: 5102
• Catalog Number: 5102
• 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: false
• 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
• Special Storage Condition, Specify: Between 0 and 0 *This way up Do Not Freeze Fragile-Handle with Care Keep Dry
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *This way up Do Not Freeze Fragile-Handle with Care Keep Dry
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *This way up Do Not Freeze Fragile-Handle with Care Keep Dry
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *This way up Do Not Freeze Fragile-Handle with Care Keep Dry
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *This way up Do Not Freeze Fragile-Handle with Care Keep Dry
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *This way up Do Not Freeze Fragile-Handle with Care Keep Dry
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *This way up Do Not Freeze Fragile-Handle with Care Keep Dry
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *This way up Do Not Freeze Fragile-Handle with Care Keep Dry
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *This way up Do Not Freeze Fragile-Handle with Care Keep Dry
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *This way up Do Not Freeze Fragile-Handle with Care Keep Dry
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *This way up Do Not Freeze Fragile-Handle with Care Keep Dry
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *This way up Do Not Freeze Fragile-Handle with Care Keep Dry
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *This way up Do Not Freeze Fragile-Handle with Care Keep Dry
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *This way up Do Not Freeze Fragile-Handle with Care Keep Dry
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *This way up Do Not Freeze Fragile-Handle with Care Keep Dry
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *This way up Do Not Freeze Fragile-Handle with Care Keep Dry
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *This way up Do Not Freeze Fragile-Handle with Care Keep Dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	03607360051023 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210623

FDA Product Code

• DFH: Kappa, Antigen, Antiserum, Control

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: 2023-04-10
• Device Publish Date: 2023-03-31

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• 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