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Solesta injectable gel
PALETTE LIFE SCIENCES, INC.
Gel 1.0 mL Syringe
In Commercial Distribution
- 00850004725016 ()
- Total Volume: 1 Milliliter
011506
- Anal tissue reconstructive material
The therascreen PIK3CA RGQ PCR Kit is a real-time qualitative PCR test for the detection of 11 mutations in the phosphatidylinositol 3-kinase catalytic subunit alpha (PIK3CA) gene (Exon 7: C420R; Exon 9: E542K, E545A, E545D [1635G>T only], E545G, E545K, Q546E, Q546R; and Exon 20: H1047L, H1047R, H1047Y) using genomic DNA (gDNA) extracted from formalin-fixed, paraffin-embedded (FFPE) breast tumor tissue or circulating tumor DNA (ctDNA) from plasma derived from K2EDTA anticoagulated peripheral whole blood taken from patients with breast cancer.
The test is intended to aid clinicians in identifying breast cancer patients who may be eligible for treatment with PIQRAY® (alpelisib) based on a PIK3CA Mutation Detected result. Patients whose FFPE tissue or plasma specimen produces a positive therascreen PIK3CA RGQ PCR Kit test result for the presence of one or more PIK3CA mutations are eligible for treatment with PIQRAY (alpelisib). Patients whose plasma specimen produces a negative result using this test should be reflexed to testing with FFPE tumor tissue for the presence of PIK3CA mutations.
FFPE tumor specimens are processed using the QIAamp DSP DNA FFPE Tissue Kit for manual sample preparation. K2EDTA anticoagulated whole peripheral venous blood plasma specimens are processed using the QIAamp DSP Circulating Nucleic Acid Kit for manual sample preparation. For both specimen types, the Rotor-Gene Q (RGQ) MDx (US) instrument is used for automated amplification and detection. The Kit is to be used by trained personnel in a professional laboratory environment.
QIAGEN GmbH
V1
In Commercial Distribution
- 04053228034223 ()
873121
- PIK3CA gene mutation IVD, kit, nucleic acid technique (NAT)
Cochlear EAC200 Series Power Speaker Unit (Size 5, Left)
COCHLEAR LIMITED
Z319074
In Commercial Distribution
- 09321502024099 ()
- Size 4 Left Power Speaker Unit
Z319074
- Earphone, insert
Cochlear EAC200 Series Power Speaker Unit (Size 4, Left)
COCHLEAR LIMITED
Z319073
In Commercial Distribution
- 09321502024082 ()
- Size 3 Left Power Speaker Unit
Z319073
- Earphone, insert
Cochlear EAC200 Series Power Speaker Unit (Size 3, Left)
COCHLEAR LIMITED
Z319072
In Commercial Distribution
- 09321502024075 ()
- Size 2 Left Power Speaker Unit
Z319072
- Earphone, insert
Cochlear EAC200 Series Power Speaker Unit (Size 2, Left)
COCHLEAR LIMITED
Z319071
In Commercial Distribution
- 09321502024068 ()
- Size 1 Left Power Speaker Unit
Z319071
- Earphone, insert
Cochlear EAC200 Series Power Speaker Unit (Size 1, Left)
COCHLEAR LIMITED
Z319070
In Commercial Distribution
- 09321502024051 ()
- Size 5 Right Power Speaker Unit
Z319070
- Earphone, insert
Cochlear EAC200 Series Power Speaker Unit (Size 5, Right)
COCHLEAR LIMITED
Z319069
In Commercial Distribution
- 09321502024044 ()
- Size 4 Right Power Speaker Unit
Z319069
- Earphone, insert
Cochlear EAC200 Series Power Speaker Unit (Size 4, Right)
COCHLEAR LIMITED
Z319068
In Commercial Distribution
- 09321502024037 ()
- Size 3 Right Power Speaker Unit
Z319068
- Earphone, insert
Cochlear EAC200 Series Power Speaker Unit (Size 3, Right)
COCHLEAR LIMITED
Z319067
In Commercial Distribution
- 09321502024020 ()
- Size 2 Right Power Speaker Unit
Z319067
- Earphone, insert