PACKAGE INSERTS

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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
G203	Birlinn^™ HH Panel G203
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
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 - English Only) Customers Outside U.S. (CE-IVD - Multilingual)
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 M323v1.1
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 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
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
M509	Birlinn^™ CoV2-Flu-RSV Control Panel M509
M527	FilmArray^® TF Control Panel M527

Controls for Oncology Testing

P/N	Product Name
C104	Xpert Bladder Cancer Panel C104
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
C194v1.1	Xpert NPM1 Control Panel C194v1.1
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
C215	Xpert PML-RARA Control Panel C215
C221	Xpert PML-RARA Linearity Panel C221
C225	Xpert NPM1 Linearity Panel C225
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)