PACKAGE INSERTS

Click or tap the links below to view Package Inserts.

Controls for Inherited Disease Testing

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

 

Controls for Infectious Disease Testing

P/N Product Name
M110 INTROL® TB Panel M110
M114-5 INTROL® TB Panel M114
M114-10 INTROL® TB Panel M114
M114plus INTROL® TB Panel M114plus
M115 INTROL® TBNEG-30
M219 Xpert® Carba-R QC Panel M219
M235v1.1 FilmArray® BCID Control Panel M235 v1.1
M238 FilmArray® GI Control Panel M238
U.S. Customers (RUO)
Customers Outside U.S. (RUO)
Customers Outside U.S. (CE-IVD)
M251 FilmArray® Ebola Control Panel M251
M262 BioFire® ME Control Panel M262
U.S. Customers (RUO)
Customers Outside U.S. (RUO)
Customers Outside U.S. (CE-IVD)
M270 Verigene® RP Flex Control Panel M270
M306 ePlex RP Control M306
M31118-6 ePlex RP Negative
M320v1.1 ePlex BCID-FP Control M320 v1.1
M50137-6 ePlex BCID-FP Negative
M323v1.1 ePlex BCID-GP Control M323 v1.1
M50237-6 ePlex BCID-GP Negative
M326 ePlex BCID-GN Control M326
M50337-6 ePlex BCID-GN Negative
M340 FilmArray® Pneumonia/Pneumoniaplus Control
U.S. Customers (CE-IVD)
Customers Outside U.S. (RUO)
Customers Outside U.S. (CE-IVD)
M345-5 INTROL® TB-XDR Panel M345
M360v1.2 QIAstat-Dx RP SARS-CoV-2 Control Panel
M36321-6 QIAstat-Dx RP SARS-CoV-2 Negative
M404 Unyvero LRT/Pneumonia Control Panel M404
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
U.S. Customers (CE-IVD)
Customers Outside U.S. (RUO)
Customers Outside U.S. (CE-IVD)
M425 SPOTFIRE® RSP Pos & Neg Controls

M42638 SPOTFIRE RSP POS:
U.S. Customers (IVD)
Customers Outside U.S. (RUO)

M42738 SPOTFIRE RSP NEG:
U.S. Customers (IVD)
Customers Outside U.S. (RUO)
M430 Xpert SARS-CoV-2 Control Panel M430
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)
Customers Outside U.S. (CE-IVD)
M475 QIAstat-Dx GI 2 Control Panel

 

Controls for Oncology Testing

P/N Product Name
C130 Xpert BCR-ABL IS Panel C130
U.S. Customers (CE-IVD)
Customers Outside U.S. (RUO)
Customers Outside U.S. (CE-IVD)
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
C194 Xpert NPM1 Control Panel C194
C207 Xpert BCR-ABL IS p210 Linearity Panel C207
U.S. Customers (IVD)
Customers Outside U.S. (RUO)