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The therascreen BRAF V600E RGQ PCR Kit is a real-time PCR test for the qualitative detection of V600E mutations in the BRAF gene using genomic DNA extracted from formalin-fixed paraffin-embedded (FFPE) human colorectal cancer (CRC) tumor tissue. The therascreen BRAF V600E RGQ PCR Kit is an in vitro diagnostic device intended to be used as an aid in selecting patients with metastatic colorectal cancer (mCRC) whose tumors carry the BRAF V600E mutation for treatment with BRAFTOVI (encorafenib) in combination with cetuximab. The therascreen BRAF V600E RGQ PCR Kit is for use on the Rotor-Gene Q MDx (US)
instrument. The therascreen BRAF V600E RGQ PCR Kit is intended for in vitro diagnostic use.
QIAGEN GmbH
1
In Commercial Distribution
- 04053228035725 ()
874821
- BRAF gene mutation IVD, kit, nucleic acid technique (NAT)
The BreathTek UBT for H. pylori Kit (BreathTek UBT Kit) is intended for use in the qualitative detection of urease associated with H. pylori in the human stomach and is indicated as an aid in the initial diagnosis and post-treatment monitoring of H. pylori infection in adults, and pediatric patients 3 to 17 years old. The test may be used for monitoring treatment is used at least 4 weeks following completion of therapy. For there purposes, the system utilizes an Infrared Spectrophotometer for the measurement of the ration of 13CO2 to 12CO2 in breath samples, in clinical laboratories and point-of-care settings. The Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA), provided as a web-based calculation program, is required to obtain pediatric test results. The BreathTek UBT Kit is for administration by the heath care professional, as ordered by a licensed health care practitioner.
MERIDIAN BIOSCIENCE, INC.
01
In Commercial Distribution
- 00840733101434 ()
- 00840733101441 ()
8209
- Helicobacter pylori urease IVD, kit, chromogenic
The BreathTek® UBT for H. pylori Kit (BreathTek UBT Kit) is intended for use in the qualitative detection of urease associated with H. pylori in the human stomach and is indicated as an aid in the initial diagnosis and post-treatment monitoring of H. pylori infection in adults, and pediatric patients 3 to 17 years old. The test may be used for monitoring treatment if used at least 4 weeks following completion of therapy. For these purposes, the system utilizes an Infrared Spectrophotometer for the measurement of the ratio of 13CO2 to 12CO2 in breath samples, in clinical laboratories and point-of-care settings. The Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA), provided as a web-based calculation program, is required to obtain pediatric test results.
The BreathTek UBT Kit is for administration by a health care professional, as ordered by a licensed health care practitioner.
Otsuka America Pharmaceutical Inc
01
In Commercial Distribution
- 00857335005008 ()
- 10857335005029 ()
- Helicobacter pylori urease IVD, kit, chromogenic
The Carl Zeiss Meditec MEL 90 Excimer Laser System is designed for refractive surgery based on the ablation of corneal tissue achieved with a short pulse excimer laser having a wavelength of 193 nanometers. The laser head emits 4 to 7 nanosecond pulses (FWHM nominal pulse duration) with a repetition rate of 500 Hz. The MEL 90 Excimer Laser is a spot-scanning laser that utilizes a Gaussian beam with a 0.7 mm spot diameter.
Indications for Use:
The MEL 90 is indicated for use in primary Laser-Assisted in situ Keratomileusis (LASIK) treatments for the reduction or elimination of:
• Myopia less in magnitude than -10.00 D sphere (in minus-cylinder notation), with and without cylinder up to -4.00 D, when MRSE is less in magnitude than -10.00 D;
• Hyperopia up to +4.00 D sphere (in plus-cylinder notation), with and without cylinder up to +3.00 D, when MRSE is up to +5.00 D; and
• Mixed astigmatism with cylinder from >1.00 D up to 4.00 D;
in patients who are 18 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by a change in MRSE within +/- 0.50 D.
Carl Zeiss Meditec AG
1900-109
In Commercial Distribution
- 04049471095074 ()
- Weight: 295 Kilogram
- x W x H: 1.63 m x 0.73 m x 1.48 m to 1.70 m
- Ophthalmic excimer laser system
Battery used in addition to the power cord for the Nevisense to enable use of the Nevisense as a portable device.
Scibase AB
521-0001
In Commercial Distribution
- 07350094440194 ()
521-0001
- Neoplasm electrical impedance spectrometer
Intacs Corneal Implants are designed to reshape the anterior curvature of the cornea for the reduction or elimination of myopia and astigmatism in patients with keratoconus. The medical device consists of two clear 150-degree arc segments and are available in sizes from 0.210 to 0.450 mm.
ADDITION TECHNOLOGY, INC.
ICI-450-150
In Commercial Distribution
- 00850048576155 ()
11600-450-150
- Intracorneal ring segment
- Intracorneal ring
Intacs Corneal Implants are designed to reshape the anterior curvature of the cornea for the reduction or elimination of myopia and astigmatism in patients with keratoconus. The medical device consists of two clear 150-degree arc segments and are available in sizes from 0.210 to 0.450 mm.
ADDITION TECHNOLOGY, INC.
ICI-400-150
In Commercial Distribution
- 00850048576148 ()
11600-400-150
- Intracorneal ring segment
- Intracorneal ring
Intacs Corneal Implants are designed to reshape the anterior curvature of the cornea for the reduction or elimination of myopia and astigmatism in patients with keratoconus. The medical device consists of two clear 150-degree arc segments and are available in sizes from 0.210 to 0.450 mm.
ADDITION TECHNOLOGY, INC.
ICI-350-150
In Commercial Distribution
- 00850048576131 ()
11600-350-150
- Intracorneal ring segment
- Intracorneal ring
Intacs Corneal Implants are designed to reshape the anterior curvature of the cornea for the reduction or elimination of myopia and astigmatism in patients with keratoconus. The medical device consists of two clear 150-degree arc segments and are available in sizes from 0.210 to 0.450 mm.
ADDITION TECHNOLOGY, INC.
ICI-300-150
In Commercial Distribution
- 00850048576124 ()
11600-300-150
- Intracorneal ring segment
- Intracorneal ring
Intacs Corneal Implants are designed to reshape the anterior curvature of the cornea for the reduction or elimination of myopia and astigmatism in patients with keratoconus. The medical device consists of two clear 150-degree arc segments and are available in sizes from 0.210 to 0.450 mm.
ADDITION TECHNOLOGY, INC.
ICI-250-150
In Commercial Distribution
- 00850048576117 ()
11600-250-150
- Intracorneal ring segment
- Intracorneal ring