CAPILLARYS 3 DBS MICROPLATES 2578

GUDID 03607360025789

MICROPLATES ARE AN ACCESSORY _PLASTIC PLATES

SEBIA

Microplate IVD

• Primary Device ID: 03607360025789
• NIH Device Record Key: ff4a5226-c102-4788-853c-839f98b35cfa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CAPILLARYS 3 DBS MICROPLATES
• Version Model Number: 2578
• Catalog Number: 2578
• 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: false
• 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 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03607360025789 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232027

FDA Product Code

• GKA: Abnormal Hemoglobin Quantitation

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: 2024-05-08
• Device Publish Date: 2024-04-30

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