ANTISERUM AND FIXATIVE SOLUTION FOR HYDRAGEL 12 IF Penta MAXI-KIT(STANDARD MASK) 4819

GUDID 03607360048191

ANTISERUM AND FIXATIVE SOLUTION FOR HYDRAGEL 12 IF Penta MAXI-KIT (STANDARD MASK)

SEBIA

Multiple clinical chemistry protein IVD, reagent

• Primary Device ID: 03607360048191
• NIH Device Record Key: b0a79b23-b5f0-4c17-bb93-9356a068823b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ANTISERUM AND FIXATIVE SOLUTION FOR HYDRAGEL 12 IF Penta MAXI-KIT(STANDARD MASK)
• Version Model Number: 4819
• Catalog Number: 4819
• 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
• Special Storage Condition, Specify: Between 0 and 0 *FRAGLE HANDLE WITH CARE
• Special Storage Condition, Specify: Between 0 and 0 *AVOID CONTACT WITH WATER
• Special Storage Condition, Specify: Between 0 and 0 *THIS WAY UP
• Special Storage Condition, Specify: Between 0 and 0 *Consult Instructions for Use, Logo GHS07
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *FRAGLE HANDLE WITH CARE
• Special Storage Condition, Specify: Between 0 and 0 *AVOID CONTACT WITH WATER
• Special Storage Condition, Specify: Between 0 and 0 *THIS WAY UP
• Special Storage Condition, Specify: Between 0 and 0 *Consult Instructions for Use, Logo GHS07
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *FRAGLE HANDLE WITH CARE
• Special Storage Condition, Specify: Between 0 and 0 *AVOID CONTACT WITH WATER
• Special Storage Condition, Specify: Between 0 and 0 *THIS WAY UP
• Special Storage Condition, Specify: Between 0 and 0 *Consult Instructions for Use, Logo GHS07
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *FRAGLE HANDLE WITH CARE
• Special Storage Condition, Specify: Between 0 and 0 *AVOID CONTACT WITH WATER
• Special Storage Condition, Specify: Between 0 and 0 *THIS WAY UP
• Special Storage Condition, Specify: Between 0 and 0 *Consult Instructions for Use, Logo GHS07

Device Identifiers

Device Issuing Agency	Device ID
GS1	03607360048191 [Primary]

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: 2026-01-19
• Device Publish Date: 2026-01-09

Devices Manufactured by SEBIA

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• 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): 2026-01-19ANTISERUM AND FIXATIVE SOLUTION FOR HYDRAGEL 12 IF Penta 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