Package Inserts (PIs)

 

Controls for Inherited Disease Testing

P/N Product Name
G106ac INTROL® CF Panel I Control v.02
U.S. Customers (IVD)
Customers Outside U.S. (RUO)
Customers Outside U.S. (CE-IVD)
G108-2H Xpert FII & FV HET
Download
G109 Xpert FII & FV Genotype Panel G109
US Customers (RUO, EN)
EU Customers (CE-IVD, ML)
Customers Outside US & EU (RUO, EN)
G110 INTROL® CF Panel II Control
Download
G115 INTROL® CF Panel III Control
Download
G11601 Xpert FII & FV NOR/MUT Control
Download
G123-1 INTROL® Thrombosis Genotype Panel
Download
G203 Birlinn HH Panel G203
Download
G211v1.1 NGS CF Control Panel G211 v1.1
All Customers (RUO, EN)
G211plus NGS CF Control Panel G211plus
All Customers (RUO, EN)

 

Controls for Infectious Disease Testing

P/N Product Name
M110 INTROL® TB Panel M110
Download
M114-5 INTROL® TB Panel M114
Download
M114-10 INTROL® TB Panel M114
Download
M114plus INTROL® TB Panel M114plus
Download
M115 INTROL® TBNEG-30
Download
M219 Xpert® Carba-R QC Panel M219
Download
M238 FilmArray® GI Control Panel M238
US Customers (IVD, EN)
EU Customers (CE-IVD, ML)
Customers Outside US & EU (RUO, EN)
M251 FilmArray® Ebola Control Panel M251
Download
M262 BioFire® ME Control Panel M262
U.S. Customers (RUO)
Customers Outside U.S. (RUO - English Only)
Customers Outside U.S. (CE-IVD - Multilingual)
M270 Verigene® RP Flex Control Panel M270
Download
M306 ePlex RP Control M306
Download
M31118-6 ePlex RP Negative
Download
M320v1.1 eplex BCID-FP Control M320 v1.1
Download
M50137-6 eplex BCID-FP Negative
Download
M323v1.1 eplex BCID-GP Control M323v1.1
Download
M50237-6 eplex BCID-GP Negative
Download
M326 eplex BCID-GN Control M326
Download
M50337-6 eplex BCID-GN Negative
Download
M340 FilmArray® Pneumonia/Pneumoniaplus Control
US Customers (IVD, EN)
EU Customers (CE-IVD, ML)
Customers Outside US & EU (RUO, EN)
M345-5 INTROL® TB-XDR Panel M345
Download
M360v1.2 QIAstat-Dx RP SARS-CoV-2 Control Panel
Download
M36321-6 QIAstat-Dx RP SARS-CoV-2 Negative
Download
M404 Unyvero LRT/Pneumonia Control Panel M404
Download
M416 FilmArray® BCID2 Control Panel M416
U.S. Customers (CE-IVD)
Customers Outside U.S. (RUO)
Customers Outside U.S. (CE-IVD)
M420 BioFire® JI Control Panel M420
US Customers (CE-IVD)
Customers Outside U.S. (RUO)
Customers Outside U.S. (CE-IVD)
M425 SPOTFIRE® RSP Pos & Neg Controls
U.S. Customers (IVD)
Customers Outside U.S. (RUO)
M42638 SPOTFIRE® RSP Positive Control
U.S. Customers (IVD)
Customers Outside U.S. (RUO)
M42738 SPOTFIRE® RSP Negative Control
U.S. Customers (IVD)
Customers Outside U.S. (RUO)
M430 Xpert SARS-CoV-2 Control Panel M430
Download
M441 BioFire® RP2.1/RP2.1plus Control Panel M441
U.S. Customers (CE-IVD)
Customers Outside U.S. (RUO)
Customers Outside U.S. (CE-IVD)
M451 eplex RP2 Control M451
U.S. Customers (RUO)
Customers Outside U.S. (RUO - English Only)
Customers Outside U.S. (CE-IVD - Multilingual)
M475 QIAstat-Dx GI 2 Control Panel
Download
M509 Birlinn CoV2-Flu-RSV Control Panel M509
Non-US Customers (RUO, EN)
US customers (IVD, EN)
M527 FilmArray® TF Control Panel M527
Download

 

Controls for Oncology Testing

P/N Product Name
C104 Xpert Bladder Cancer Panel C104
All Customers (RUO, ML)
C130 Xpert BCR-ABL IS Panel C130
US Customers (CE-IVD)
Customers Outside US & EU (RUO, EN)
EU Customers (CE-IVD, ML)
C13112-5 Xpert BCR-ABL 0%IS
U.S. Customers (CE-IVD)
Customers Outside U.S. (RUO)
Customers Outside U.S. (CE-IVD)
C183 Xpert BCR-ABL1 p190 Control Panel C183
Download
C194v1.1 Xpert NPM1 Control Panel C194v1.1
Download
C207 Xpert BCR-ABL IS p210 Linearity Panel C207
U.S. Customers (IVD)
Customers Outside U.S. (RUO)
C208 Xpert BCR-ABL1 p190 Linearity Panel C208
Download
C215 Xpert PML-RARA Control Panel C215
Download
C221 Xpert PML-RARA Linearity Panel C221
Download
C225 Xpert NPM1 Linearity Panel C225
Download
C230 Birlinn BCR-ABL1 p210 IS Panel C230
U.S. Customers (IVD)
Customers Outside U.S. (RUO)
C240 Birlinn BCR-ABL1 p210 IS Control Panel C240
U.S. Customers (IVD)
Customers Outside U.S. (RUO)