FLC Lambda 5103

GUDID 03607360051030

SEBIA

Kappa/lambda light chain immunoglobulin IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 03607360051030
• NIH Device Record Key: 324d38c0-4c80-4eca-a6df-0ec519b4fd05
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FLC Lambda
• Version Model Number: 5103
• Catalog Number: 5103
• 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	03607360051030 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210623

FDA Product Code

• DEH: Lambda, 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

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