HYDRASHIFT 2 4 daratumumab 20 tests 4639

GUDID 03607360046395

SEBIA

Multiple clinical chemistry protein IVD, reagent

• Primary Device ID: 03607360046395
• NIH Device Record Key: dae027af-0127-45a9-86b1-363f96a78250
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HYDRASHIFT 2 4 daratumumab 20 tests
• Version Model Number: 4639
• Catalog Number: 4639
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03607360046395 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190851

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: 2019-07-09
• Device Publish Date: 2019-07-01

Devices Manufactured by SEBIA

• 03607360043165 - ANTISERA AND FIXATIVE SOLUTION FOR HYDRAGEL 4 & 9 IF MAXI-KIT (DYNAMIC MASK): 2026-01-19
• 03607360043189 - ANTISERA AND FIXATIVE SOLUTION FOR HYDRAGEL 9 BENCE JONES MAXI-KIT(DYNAMIC MASK): 2026-01-19
• 03607360043875 - HYDRAGEL 9 IF MAXI-KIT WITHOUT ANTISERUM (DYNAMIC MASK): 2026-01-19
• 03607360048160 - ANTISERA AND FIXATIVE SOLUTION FOR HYDRAGEL 4 IF MAXI-KIT (STANDARD MASK): 2026-01-19
• 03607360048177 - ANTISERA AND FIXATIVE SOLUTION FOR HYDRAGEL 9 IF MAXI-KIT (STANDARD MASK): 2026-01-19
• 03607360048184 - ANTISERA AND FIXATIVE SOLUTION FOR HYDRAGEL 9 BENCE JONESMAXI-KIT(STANDARD MASK): 2026-01-19 ANTISERA AND FIXATIVE SOLUTION FOR HYDRAGEL 9 BENCE JONES MAXI-KIT (STANDARD MASK)
• 03607360048191 - ANTISERUM AND FIXATIVE SOLUTION FOR HYDRAGEL 12 IF Penta MAXI-KIT(STANDARD MASK): 2026-01-19 ANTISERUM AND FIXATIVE SOLUTION FOR HYDRAGEL 12 IF Penta MAXI-KIT (STANDARD MASK)
• 03607360043196 - ANTISERUM AND FIXATIVE SOLUTION FOR HYDRAGEL 12 IF Penta MAXI-KIT (DYNAMIC MASK): 2026-01-16