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The xReader System consists of a small, portable high resolution flatbed scanner, customized Software, and lateral flow tests that are intended for use in the system. The scanner has a custom Scanner Lid with an opening for the test device, and a Scanner Stand, which places the scanner bed at the appropriate angle for running and reading the test devices. The xReader System is intended for use with the xCup, which is a rapid, single use, disposable immunochromatographic test for the qualitative detection of drugs of abuse in human urine.
The xReader System detects drug classes at the following cutoff concentrations: Amphetamines at 500 ng/mL; Barbiturates at 300 ng/mL; Benzodiazepines at 300 ng/mL; Cocaine at 150 ng/mL; Methamphetamines at 500 ng/mL; Methadone at 300 ng/mL; Morphine at 300 ng/mL and 2000 ng/mL; Oxycodone at 100 ng/mL; Phencyclidine at 25 ng/mL; and Marijuana at 50 ng/mL. Configurations of the xCup may consist of any combination of the listed drug analytes.
The xCup test devices are run in the xReader System according to their specific instructions for use. At the conclusion of the test an image is captured and the Software determines whether the colored test lines for each analyte are above or below the threshold associated with a Send to Lab or a Discard result. The Software also confirms the validity of the results by verifying the presence of control lines and analyzing the specimen validity. The xReader System is for in vitro diagnostic use and is intended for use in laboratories, point-of-care sites and workplaces by minimally trained users. The test is not intended for over-the-counter use. The xCup test devices cannot be read visually.
ESCREEN, INC.
BS-0610S
In Commercial Distribution
- 00867802000290 ()
301
- Photometric/spectroscopic immunoassay analyser IVD
Portable, battery powered laser therapy device emitting up to 1.5 W at 635/405nm in CW or pulsed modes.
AVANT WELLNESS SYSTEMS INC.
LZ30 Revi
In Commercial Distribution
- 00852116008186 ()
- Musculoskeletal/physical therapy laser, professional
Portable, battery powered laser therapy device emitting up to 1.5 W at 635/808nm in CW or pulsed modes.
AVANT WELLNESS SYSTEMS INC.
LZ30 ProZ
In Commercial Distribution
- 00852116008179 ()
- Musculoskeletal/physical therapy laser, professional
Portable, battery powered laser therapy device emitting up to 1.5 W at 635/405nm in CW or pulsed modes.
AVANT WELLNESS SYSTEMS INC.
LZ30-Revi
Not in Commercial Distribution
- 00852116008087 ()
- Musculoskeletal/physical therapy laser, professional
Portable, battery powered laser therapy device emitting up to 0.8 W at 635/808nm in CW or pulsed modes.
AVANT WELLNESS SYSTEMS INC.
LZ30-Home
Not in Commercial Distribution
- 00852116008070 ()
- Musculoskeletal/physical therapy laser, professional
Portable, battery powered laser therapy device emitting up to 1 W at 635/808nm in CW or pulsed modes.
AVANT WELLNESS SYSTEMS INC.
LZ30-ProX
Not in Commercial Distribution
- 00852116008063 ()
- Musculoskeletal/physical therapy laser, professional
Portable, battery powered laser therapy device emitting up to 1.5 W at 635/808nm in CW or pulsed modes.
AVANT WELLNESS SYSTEMS INC.
LZ30-ProZ
Not in Commercial Distribution
- 00852116008056 ()
- Musculoskeletal/physical therapy laser, professional
Portable, battery powered laser therapy device emitting up to 0.8 W at 635/808nm in CW or pulsed modes.
AVANT WELLNESS SYSTEMS INC.
LZ30-P
Not in Commercial Distribution
- 00852116008025 ()
- Musculoskeletal/physical therapy laser, professional
Portable, battery powered laser therapy device emitting up to 1 W at 635/808nm in CW or pulsed modes.
AVANT WELLNESS SYSTEMS INC.
LZ30-X
Not in Commercial Distribution
- 00852116008018 ()
- Musculoskeletal/physical therapy laser, professional
Portable, battery powered laser therapy device emitting up to 1.5 W at 635/808nm in CW or pulsed modes.
AVANT WELLNESS SYSTEMS INC.
LZ30-Z
Not in Commercial Distribution
- 00852116008001 ()
- Musculoskeletal/physical therapy laser, professional
The FlexBoard Model 4400 is an adjustable wrist support device that extends the patient's wrist at a desired angle.
Semler Technologies, Inc.
4400
In Commercial Distribution
- 20815614020269 ()
- 10815614020262 ()
140-0400-00
- Wrist immobilizer, single-use
The WristAssist Model 4300 is a wrist support device that extends the patient's wrist at a consistent 30° angle.
Semler Technologies, Inc.
4300
In Commercial Distribution
- 20815614020177 ()
- 10815614020170 ()
- 30815614020174 ()
140-0300-00
- Wrist immobilizer, single-use
The mBrace Model 4200 is a wrist support device that extends the patient's wrist at a consistent 40° angle.
Semler Technologies, Inc.
4200
In Commercial Distribution
- 10815614020125 ()
- 20815614020122 ()
140-0200-00
- Wrist immobilizer, single-use
Elvarex 3/Thigh high without foot/Knee Comfort/Thigh high slip form without volant to sew at body bandage
BSN-Jobst GmbH
79445-00040-00
In Commercial Distribution
- 04019702282160 ()
- Pressure: 34-46 mmHg
- Compression/pressure sock/stocking, reusable
Elvarex 2/Thigh high without foot/Knee Comfort/Thigh high slip form without volant to sew at body bandage
BSN-Jobst GmbH
79447-00038-00
In Commercial Distribution
- 04019702281361 ()
- Pressure: 23-32 mmHg
- Compression/pressure sock/stocking, reusable
Elvarex 3/Thigh high without foot/Knee Comfort/Thigh high slip form without volant to sew at body bandage
BSN-Jobst GmbH
79448-00034-00
In Commercial Distribution
- 04019702277777 ()
- Pressure: 34-46 mmHg
- Compression/pressure sock/stocking, reusable
Elvarex Forte 3/Thigh high without foot/Thigh high slip form without volant to sew at body bandage/Black
BSN-Jobst GmbH
79497-00005-00
In Commercial Distribution
- 04019702276701 ()
- Pressure: 34-46 mmHg
- Compression/pressure sock/stocking, reusable
Troutman-Barraquer colibri corneal forceps, 2 7/8'', 0.5mm 1x2 teeth set at 45 degrees, 6.0mm tying platforms, flat handle
AMBLER SURGICAL CORP.
Troutman-Barraquer colibri corneal forceps
In Commercial Distribution
- 00190660076139 ()
2227E
- Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
Troutman-Barraquer colibri corneal forceps, 2 7/8'', 0.3mm 1x2 teeth set at 90 degrees, 6.0mm tying platforms, flat handle
AMBLER SURGICAL CORP.
Troutman-Barraquer colibri corneal forceps
In Commercial Distribution
- 00190660076115 ()
2223E
- Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
REEH stitch scissors w/ ribbon handle, sharp tips w/ small hook at end of one blade, 3 3/4"
BR Surgical, LLC
BR08-35463
In Commercial Distribution
- 00840183502904 ()
BR08-35463
- Suture scissors