Global Trade Item Numbers (GTINs)

 

To ensure compliance with global regulatory standards and to support robust product traceability, all of MMQCI’s IVD and CE-IVD products are assigned a unique Global Trade Item Number (GTIN). The GTIN is a globally recognized identifier governed by GS1 standards and plays a critical role in accurate product identification throughout the entire product lifecycle—from manufacturing and distribution to clinical use and post-market surveillance. In alignment with international regulatory frameworks, the use of GTINs allows our products to be precisely cataloged and seamlessly integrated into global healthcare databases, electronic health records, and inventory management systems.

By leveraging GTINs, MMQCI ensures that each product listing maintains standardized information across all distribution channels. This includes consistent labeling, accurate pricing, real-time stock availability, and interoperability with regulatory and clinical systems worldwide. Ultimately, our commitment to using GTINs reflects our dedication to transparency, quality assurance, and patient safety at every level of the supply chain.

The list below includes GTIN numbers for all MMQCI products that have received regulatory approval.

 

Inherited Disease Testing

P/N Product Name Regulatory Status GTIN
G106ac-1 INTROL® CF Panel I Control v.02 CE-IVD & IVD 00852720008008
G106ac INTROL® CF Panel I Control v.02 CE-IVD & IVD 00852720008015

 

Infectious Disease Testing

P/N Product Name Regulatory Status GTIN
M340 FilmArray® Pneumonia/Pneumoniaplus Control CE-IVD & IVD 00852720008022
M416 FilmArray® BCID2 Control Panel M416 CE-IVD & IVD 00852720008077
M420 BioFire® JI Control Panel M420 CE-IVD & IVD 00852720008121
M425 SPOTFIRE® RSP Pos & Neg Controls IVD 00852720008145
M42638 SPOTFIRE® RSP Positive Control IVD 00852720008091
M42738 SPOTFIRE® RSP Negative Control IVD 00852720008107
M441 BioFire® RP2.1/RP2.1plus Control Panel M441 CE-IVD & IVD 00852720008114

 

Oncology Testing

P/N Product Name Regulatory Status GTIN
C130 Xpert BCR-ABL IS Panel C130 CE-IVD & IVD 00852720008060
C13112-5 Xpert BCR-ABL 0%IS CE-IVD & IVD 00852720008084
C207 Xpert BCR-ABL IS p210 Linearity Panel C207 IVD 00852720008183