Life Technologies Corporation

Catalog #18081020, Lot #1368760 & Lot #1312093

Immunology and Microbiology Devices

3

No

USA Nationwide Distribution in the states of DE, IA, MN, and NC.

HSV 2 Primers, Catalog #18081020. Analyte Specific Reagent. The HSV-2 primer pair is specific for HSV-2 (Herpes Simplex Virus 2). For use in Clinical laboratories when developing their own diagnostic tests.

Lot 1705001 UDI: (01)10190302006385(17)180220(10)1705001(240)A32441

Hematology and Pathology Devices

3

No

Distributed to states: AZ, CA, NC, TX, and VA.

Oncomine Dx Target Test, (Model No. A32451), Oncomine Dx Target RNA/DNA Panel (Model No. A32441). || A qualitative In Vitro Diagnostic test.

Model # MHFH01 UDI (01)10190302005579(17)180430 (10)1626670D(240)MHFH01  Lot# 1626670D  Model # MHFH01 UDI (01)10190302005579(17)190830 (10)1873068B(240)MHFH01 Lot# 1873068B  Model # MHFH01 UDI (01)10190302005579(17)191030 (10)1915224B(240)MHFH01  Lot# 1915224B

Hematology and Pathology Devices

2

No

MI, CA, IL, TX, SC, NY, MN, DE, NJ, WA , OR, IN, MA, DE, FL, PA

Human Fetal Hemoglobin (HBF-1) FITC Conjugate

Lot Numbers: v1.8 (Rev. C) (REVC20170906) and v1.8 (Rev. C) (REVC27JUN2017)  UDI: (01)10190302006071

Hematology and Pathology Devices

3

No

US Distribution to the states of: AZ, CA, NC, TX, and VA.

Oncomine Dx Target Test User Guides and Assay Definition File, Model: A32461; UDI: (01)10190302006071(11)170911(10)1.8(240)A32461 || The Oncomine Dx Target Test is a qualitative in vitro diagnostic test that uses targeted high- throughput, parallel-sequencing technology to detect single-nucleotide variants (SNVs) and deletions in 23 genes from DNA and fusions in ROS1 from RNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue samples from patients with non-small cell lung cancer (NSCLC) using the Ion PGM Dx System. The test is indicated to aid in selecting NSCLC patients for treatment with the targeted therapies listed in Table 1 in accordance with the approved therapeutic product labeling.