(2) Reagent Pack B.

1 bottle (0.9 mL) HCV Genotype II Oligonucleotide Reagent B. Less than 0.1% synthetic

oligonucleotides (6 primers, 5 probes), less than 0.1% dNTPs, and 10.4% dimethylsulfoxide in a

buffered solution with a reference dye. Preservatives: 0.1% ProClin 300 and 0.15% ProClin 950.

1 bottle (0.141 mL) Thermostable rTth Polymerase Enzyme (2.9 to 3.5 Units/µL) in buffered solution. 1 bottle (0.400 mL) Activation Reagent, 30 mM manganese chloride solution.

Preservatives: 0.1% ProClin 300 and 0.15% ProClin 950. (3) Reagent Pack C.

1 bottle (0.9 mL) HCV Genotype II Oligonucleotide Reagent C. Less than 0.1% synthetic

oligonucleotides (4 primers, 4 probes), less than 0.1% dNTPs, and 10.4% dimethylsulfoxide in a

buffered solution with a reference dye. Preservatives: 0.1% ProClin 300 and 0.15% ProClin 950.

1 bottle (0.141 mL) Thermostable rTth Polymerase Enzyme (2.9 to 3.5 Units/µL) in buffered solution. 1 bottle (0.400 mL) Activation Reagent, 30 mM manganese chloride solution.

Preservatives: 0.1% ProClin 300 and 0.15% ProClin 950.

NOTE: Amplification reagents are intended for single-use only. Residual reagent will remain in the reagent pack bottles after use. Unused reagents should be discarded.

Abbott RealTime HCV Genotype II Control Kit (List No. 08L21-80)

1.

Abbott RealTime HCV Genotype II Negative Control (List No. 8L21Z)

(4 vials, 1.3 mL per vial)

Negative human plasma tested and found to be nonreactive by FDA licensed tests for antibody to HCV, antibody to HIV-1, antibody to HIV-2, and HBsAg. The material is also tested and found to be negative by FDA licensed PCR methods for HIV-1 RNA and HCV RNA. Preservatives: 0.1% ProClin 300 and 0.15% ProClin 950.

Abbott RealTime HCV Genotype II Positive Control (List No. 8L21W)

(4 vials, 1.3 mL per vial)

Noninfectious Armored RNA representing the 5′ untranslated region (5′ UTR) sequences of HCV

genotype 1a and HCV genotype 4 in negative human plasma. Negative human plasma tested and found to be nonreactive by FDA licensed tests for antibody to HCV, antibody to HIV-1, antibody to HIV-2, and HBsAg. The material is also tested and found to be negative by FDA licensed PCR methods for

HIV-1 RNA and HCV RNA. Preservatives: 0.1% ProClin 300 and 0.15% ProClin 950. 2.

NOTE: Control lots can be used interchangeably with amplification reagent kit lots.

WARNINGS AND PRECAUTIONS

In Vitro Diagnostic Medical Device

FOR IN VITRO DIAGNOSTIC USE

The Abbott RealTime HCV Genotype II assay is indicated only for individuals who have been determined to be chronically infected with HCV.

The Abbott RealTime HCV Genotype II assay is not for screening blood, plasma, serum or tissue donors for HCV, or to be used as a diagnostic test to confirm the presence of HCV infection in donated blood, plasma, serum, or tissue.

The Abbott RealTime HCV Genotype II reagents are intended to be used only on the Abbott m2000

System consisting of the Abbott m2000sp for sample processing and the Abbott m2000rt for amplification and detection.