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Company Name

• FUJIREBIO INC. (2)

Brand Name

• Lumipulse G Mesothelin Calibrator (1)
• Lumipulse G Mesothelin Immunoreaction Cartridges (1)

GMDN Term Name

• Soluble mesothelin-related peptide (SMRP) IVD, calibrator (1)
• Soluble mesothelin-related peptide (SMRP) IVD, kit, chemiluminescent immunoassay (1)

GMDN Term Status

• Active (2)

FDA Product Code Name

• Cancer Monitoring Test System, Soluble Mesothelin-Related Peptides, Epithelioid/Biphasic Mesothelioma (2)

FDA Product Code

• OAW (2)

Device Packaged As Sterile

• No (2)

Sterilization Prior To Use

• No (2)

Issuing Agency

• GS1 (2)

Device Size Type

• Size Type = Tests Per kit; Size Unit = 42; Unit of Measure = Tests (1)
• Size Type = Units per kit; Units = 3; Unit of Measure = 4.5mLs (1)

Device Class

• Humanitarian Device Exemption (2)

Implantable

• No (2)