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Lithium - Sulfur Dioxide battery for replacement in Cardiac Science(TM) Powerheart(TM) G3 9300A, 9300E, 9390A, 9390E, and Burdick Cardiovive AT. Color blue.
AED BATTERY EXCHANGE, LLC
9146-B-ABE
In Commercial Distribution
- 00864312000246 ()
- Primary battery
Software used in combination with the THxIDTM- BRAF assay
(used to identify patients with melanoma whose tumors harbor the BRAF V600E/K mutations)
BIOMERIEUX SA
1.0
In Commercial Distribution
- 03573026559823 ()
- BRAF gene mutation IVD, kit, nucleic acid technique (NAT)
The Access Hybritech p2PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of [-2]proPSA antigen, an isoform of free PSA, in human serum using the Access Immunoassay Systems. Access Hybritech p2PSA is intended to be used in combination with Access Hybritech (total) PSA and Access Hybritech free PSA to calculate the Beckman Coulter Prostate Health Index (phi), an In Vitro Diagnostic Multivariate Index
Assay (IVDMIA). Beckman Coulter phi as calculated using the Access Hybritech assays is indicated for use as an aid in distinguishing prostate cancer from benign prostatic conditions, for prostate cancer detection in men aged 50 years and older with total PSA ≥ 4.0 to ≤ 10.0 ng/mL, and with digital rectal examination findings that are not suspicious for cancer. Prostatic biopsy is required for diagnosis of cancer.
Beckman Coulter, Inc.
B03704
In Commercial Distribution
- H628B037041 ()
B03704
- Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay
The therascreen FGFR RGQ RT-PCR Kit is a real-time, reverse transcription PCR test for the qualitative detection of two point mutations in exon 7 [p.R248C (c.742C>T), p.S249C (c.746C>G)], two point mutations in exon 10 [p.G370C (c.1108G>T) and p.Y373C (c.1118A>G)] and two fusions (FGFR3-TACC3v1 and FGFR3-TACC3v3) in the fibroblast growth factor receptor 3 (FGFR3) gene in RNA samples derived from formalin-fixed paraffin-embedded (FFPE) urothelial tumor tissue. The test is indicated for use as an aid in identifying patients with cases of urothelial cancer (UC) which harbor these alterations and are therefore eligible for treatment with BALVERSA™ (erdafitinib).
Specimens are processed using the RNeasy DSP FFPE Kit for manual sample preparation followed by reverse transcription and then automated amplification and detection on the Rotor-Gene Q MDx (US) instrument.
QIAGEN GmbH
2
In Commercial Distribution
- 04053228043560 ()
874721
- Fibroblast growth factor receptor (FGFR) gene mutation IVD, kit, nucleic acid technique (NAT)
TriVisc™ 850 sodium hyaluronate (P160057) is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen. TriVisc is a sterile, viscoelastic, non-pyrogenic solution (pH of 6.8-7.8) of highly purified, high molecular weight hyaluronic acid (HA) with an average molecular weight of 850,000 daltons and a range of 620,000 – 1,170,000 daltons). The HA is a polymer of repeating disaccharide units of glucuronic acid and N-acetyl-glucosamine derived from a bacterial fermentation process. TriVisc is supplied in a prefilled syringe containing 25 mg of HA in 2.5 mL of physiological saline solution (1% solution).
Avanos Medical, Inc.
50653-0006-04
In Commercial Distribution
- 10850653006044 ()
- 00850653006047 ()
- 20850653006041 ()
- Synovial fluid supplementation medium
Lithium - Sulfur Dioxide battery for replacement in Cardiac Science(TM) Powerheart(TM) G3 9300A,, 9300E, 9390A, 9390E and Burdick Cardiovive AT (TM). Color White.
AED BATTERY EXCHANGE, LLC
9146-W-ABE
In Commercial Distribution
- 00864312000253 ()
- Primary battery
Lithium - Sulfur Dioxide battery for replacement in Cardiac Science(TM) Powerheart(TM) G3 9300A, 9300E, 9390A, 9390E, and Burdick Cardiovive AT (TM). Color Yellow.
AED BATTERY EXCHANGE, LLC
9146-Y-ABE
In Commercial Distribution
- 00864312000239 ()
- Primary battery
Millennia Acupuncture Needle is well known for its superior quality, affordability and performance. It is one of the best acupuncture needles in the world.
UPC MEDICAL SUPPLIES, INC.
A-1M 0.35 X 40
In Commercial Distribution
- 00831592003342 ()
- 00008315920000 ()
- Length: 40 Millimeter
- Outer Diameter: 0.35 Millimeter
- Acupuncture needle, single-use
Foldable, posterior chamber intraocular lens (IOL), preloaded in an injector that automatically folds the lens as it is advanced, prior to insertion. Single use.
HOYA MEDICAL SINGAPORE PTE. LTD.
PREVUE (yellow), +27.50D
In Commercial Distribution
- 10757770564757 ()
- Posterior-chamber intraocular lens, pseudophakic
Foldable, posterior chamber intraocular lens (IOL), preloaded in an injector that automatically folds the lens as it is advanced, prior to insertion. Single use.
HOYA MEDICAL SINGAPORE PTE. LTD.
PREVUE (yellow), +27.00D
In Commercial Distribution
- 10757770564740 ()
- Posterior-chamber intraocular lens, pseudophakic