Sample Diluent CAPI 3 IT (10) 2602

GUDID 03607360026021

SEBIA

Multiple clinical chemistry protein IVD, reagent Multiple clinical chemistry protein IVD, reagent Multiple clinical chemistry protein IVD, reagent Multiple clinical chemistry protein IVD, reagent Multiple clinical chemistry protein IVD, reagent Multiple clinical chemistry protein IVD, reagent Multiple clinical chemistry protein IVD, reagent Multiple clinical chemistry protein IVD, reagent Multiple clinical chemistry protein IVD, reagent Multiple clinical chemistry protein IVD, reagent Multiple clinical chemistry protein IVD, reagent Multiple clinical chemistry protein IVD, reagent Multiple clinical chemistry protein IVD, reagent Multiple clinical chemistry protein IVD, reagent Multiple clinical chemistry protein IVD, reagent Multiple clinical chemistry protein IVD, reagent Multiple clinical chemistry protein IVD, reagent Multiple clinical chemistry protein IVD, reagent

• Primary Device ID: 03607360026021
• NIH Device Record Key: f5b2f71d-1cea-43a0-a228-dcfbb049a546
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sample Diluent CAPI 3 IT (10)
• Version Model Number: 2602
• Catalog Number: 2602
• 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

• Special Storage Condition, Specify: Between 0 and 0 *This Way Up Fragile Handle with Care Keep Dry
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *This Way Up Fragile Handle with Care Keep Dry
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *This Way Up Fragile Handle with Care Keep Dry
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *This Way Up Fragile Handle with Care Keep Dry
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *This Way Up Fragile Handle with Care Keep Dry
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *This Way Up Fragile Handle with Care Keep Dry
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *This Way Up Fragile Handle with Care Keep Dry
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *This Way Up Fragile Handle with Care Keep Dry
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *This Way Up Fragile Handle with Care Keep Dry
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *This Way Up Fragile Handle with Care Keep Dry
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *This Way Up Fragile Handle with Care Keep Dry
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *This Way Up Fragile Handle with Care Keep Dry
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *This Way Up Fragile Handle with Care Keep Dry
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *This Way Up Fragile Handle with Care Keep Dry
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *This Way Up Fragile Handle with Care Keep Dry
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *This Way Up Fragile Handle with Care Keep Dry
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *This Way Up Fragile Handle with Care Keep Dry
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *This Way Up Fragile Handle with Care Keep Dry
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03607360026021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161928

FDA Product Code

• CFF: Immunoelectrophoretic, Immunoglobulins, (G, A, M)

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: 2023-12-07
• Device Publish Date: 2023-11-29

Devices Manufactured by SEBIA

• 03607360026014 - ANTISERA CAPI 3 IT (10): 2023-12-07
• 03607360026021 - Sample Diluent CAPI 3 IT (10): 2023-12-07
• 03607360026021 - Sample Diluent CAPI 3 IT (10): 2023-12-07
• 03607360020098 - CAPILLARYS CDT: 2023-09-13 CARBOHYDRATE DEF TRANSFERRING BY CE
• 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