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3100B DISPOSABLE SHIP KIT,BOX OF 4-HRC
Carefusion Corporation
11744-HRCK
Not in Commercial Distribution
- 10846446003567 ()
- 00846446003560 ()
11744-HRCK
- Ventilator breathing circuit, single-use
3100B Disposables Kit, Box of 4 / HRC
VYAIRE MEDICAL, INC.
29028-017
Not in Commercial Distribution
- 50190752159875 ()
29028-017
- Ventilator breathing circuit, single-use
3100B Disposables Kit, Box of 4 / HRC
VYAIRE MEDICAL, INC.
11744-HRCK
In Commercial Distribution
- 50190752158915 ()
11744-HRCK
- Ventilator breathing circuit, single-use
NMP22 BladderChek Test is an in vitro immunoassay intended for the qualitative detection of the nuclear mitotic apparatus protein (NuMA) in urine of persons with risk factors or symptoms of bladder cancer or with a history of bladder cancer.
Alere Scarborough, Inc.
D1200
In Commercial Distribution
- 00811877011538 ()
- Nuclear matrix protein 22 IVD, kit, rapid ICT, clinical
Transducer Replicas
Envoy Medical Corporation
1510
In Commercial Distribution
- 00812282020290 ()
- Surgical Replica of Model 7004 Sensor
- Surgical Replica of Model 7002 Sensor
- Surgical Replica of Model 7504 Driver
- Surgical Replica of Model 7502 Driver
901510-001
- Fully-implantable middle ear implant system
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
The Alere NMP22 BladderChek Test is an in vitro immunoassay intended for the qualitative detection of the nuclear mitotic apparatus protein (NuMA) in urine of persons with risk factors or symptoms of bladder cancer or with a history of bladder cancer.
Alere Scarborough, Inc.
D1300
Not in Commercial Distribution
- 10811877010774 ()
- Nuclear matrix protein 22 IVD, kit, rapid ICT, clinical
The Alere NMP22 BladderChek Test is an in vitro immunoassay intended for the qualitative detection of the nuclear mitotic apparatus protein (NuMA) in urine of persons with risk factors or symptoms of bladder cancer or with a history of bladder cancer.
Alere Scarborough, Inc.
D1200
Not in Commercial Distribution
- 10811877010569 ()
- Nuclear matrix protein 22 IVD, kit, rapid ICT, clinical
Approval for the use of t-cell xtend reagent with the t-spot. Tb test, in order to extend the time from sample collection to sample processing from within 8 hours of venipuncture to between 23 and 30 hours post venipuncture; and to make a technical correction to the t-spot. Tb test package insert to change the number of blood collection tubes required from (2) 6 ml heparin tubes to (1) 6 ml heparin tube. The t-cell xtend reagent is indicated for use with the t-spot. Tb test for the pre-treatment of whole blood prior to lymphocyte separation. The reagent aids in the removal of selected white blood cells from whole blood stored at room temperature (18-25 degrees c).
Oxford Immunotec, Inc.
TTK.650
In Commercial Distribution
- 15051716000053 ()
TTK.650US
- Cell centrifugation/density gradient separation reagent IVD
Approval for the use of t-cell xtend reagent with the t-spot. Tb test, in order to extend the time from sample collection to sample processing from within 8 hours of venepuncture to between 23 and 30 hours post venepuncture; and to make a technical correction to the t-spot. Tb test package insert to change the number of blood collection tubes required from (2) 6 ml heparin tubes to (1) 6 ml heparin tube. The t-cell xtend reagent is indicated for use with the t-spot. Tb test for the pre-treatment of whole blood prior to lymphocyte separation. The reagent aids in the removal of selected white blood cells from whole blood stored at room temperature (18-25 degrees c).
Oxford Immunotec, Inc.
TTK.610
In Commercial Distribution
- 15051716000022 ()
TTK.610US
- Cell centrifugation/density gradient separation reagent IVD