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Genomadix Cube CYP2C19 System, Test Kit, Cartridges: Contains substances for DNA extraction, PCR amplification, and detection of the CYP2C19 alleles, in three separate tubes. Each tube is specific for the detection of one of the three CYP2C19 loci.
One box of Test Kit, cartridges contains 20 cartridges; one cartridge per pouch.
The Genomadix Cube CYP2C19 Test is indicated for use with the Genomadix Cube CYP2C19 Platform.
Genomadix Inc
2
In Commercial Distribution
- ASM00101 ()
- Nucleic acid amplification mastermix kit IVD
The Idylla MSI Test, for use on the Idylla System, uses formalin-fixed, paraffin embedded (FFPE) tissue sections of human CRC tumor, from which nucleic acids are liberated, then analyzed using PCR amplification of seven monomorphic biomarkers (ACVR2A, BTBD7, DIDO1, MRE11, RYR3, SEC31A and SULF2) and subsequent melt-curve analysis. The Idylla MSI Test reports results as either microsatellite stable (MSS), or microsatellite instability high (MSI-H) or invalid.
Biocartis NV
2
In Commercial Distribution
- 15415219000758 ()
- 05415219000751 ()
- Microsatellite instability IVD, kit, nucleic acid technique (NAT)
moorFLPI2- Measurement PC Software V2
MOOR INSTRUMENTS LIMITED
2
In Commercial Distribution
- 15060484490126 ()
- Cutaneous microcirculation laser Doppler imaging device
Clinical software for micro vascular assessments in physiological research and clinical applications.
MOOR INSTRUMENTS LIMITED
2
In Commercial Distribution
- 15060484490102 ()
- Laser Doppler blood flowmeter
No Description
Directa AB
2
In Commercial Distribution
- 17310236092091 ()
609209
- Preformed dental crown, temporary
The EVA (Enhanced Visual Assessment) System is intended to provide magnified viewing of the vagina, cervix and external genitalia in order to aid in diagnosing abnormalities and selecting areas for biopsy. The EVA System is a mobile colposcope in which a smartphone is fitted and consists of a colposcope body, lens, smartphone upper and lower brackets, LED electronics, a mobile app for image capture, and online portal for image transfer and remote
viewing. The device is intended for use in hospitals, doctor's offices and remote and rural clinics.
MOBILEODT LTD
2
In Commercial Distribution
- 17290016976004 ()
- Colposcope
No Description
Everly Health, Inc.
2
In Commercial Distribution
- G7327001 ()
- Capillary blood collection set, home-use
- Oral/respiratory tract specimen container IVD, no additive/medium
No Description
Chemoment Materials Co., Ltd.
2
In Commercial Distribution
- 06976009582226 ()
- Silicone dental impression material
RIVAL TI H-PLATE 30MM
(present record replaces device with Primary DI: 18053800893760
ORTHOFIX SRL
2
In Commercial Distribution
- 18053340341240 ()
- Length: 30 Millimeter
003-H-30001
- Orthopaedic fixation plate, non-bioabsorbable, non-sterile
RIVAL TI H-PLATE 25MM
(present record replaces device with Primary DI: 18053800893753
ORTHOFIX SRL
2
In Commercial Distribution
- 18053340341233 ()
- Length: 25 Millimeter
003-H-25001
- Orthopaedic fixation plate, non-bioabsorbable, non-sterile