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
M210v1.1	FilmArray® RP Control Panel M210 v1.1
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	INTROL® BCR-ABL1 p190 Control Panel
C194	Xpert NPM1 Control Panel C194
C207	Xpert BCR-ABL IS p210 Linearity Panel C207 U.S. Customers (IVD) Customers Outside U.S. (RUO)