Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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The Piccolo® Lipid Panel Plus, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended for the in vitro quantitative determination of total cholesterol (CHOL), high-density lipoprotein cholesterol (HDL), triglycerides (TRIG), alanine aminotransferase (ALT), aspartate aminotransferase (AST), and glucose (GLU) in capillary (fingerstick) lithium heparinized whole blood, venous lithium heparinized whole blood, lithium heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. From the CHOL, HDL and TRIG determinations, low-density lipoprotein cholesterol (LDL), very low-density lipoprotein cholesterol (VLDL), non-HDL cholesterol, and a total cholesterol/high-density lipoprotein cholesterol ratio (TC/H) are calculated by the analyzer. Lipid measurements are used in the diagnosis and treatment of lipid and lipoprotein disorders, atherosclerosis, various liver and renal diseases, diabetes mellitus, and other diseases involving lipid metabolism or various endocrine disorders. The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood (venous or capillary) may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used.
ABAXIS, INC.
400-0030
In Commercial Distribution

  • EABA40000301 ()
  • EABA40000300 ()
400-0030

  • Glucose/ketone/lipid profile IVD, reagent
  • Alanine aminotransferase (ALT) IVD, reagent
  • Glucose IVD, reagent
  • Total aspartate aminotransferase (AST) IVD, reagent
The Piccolo® Comprehensive Metabolic Panel, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), calcium, chloride, creatinine, glucose, potassium, sodium, total bilirubin, total carbon dioxide, total protein, and blood urea nitrogen (BUN) in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used.
ABAXIS, INC.
400-0028
In Commercial Distribution

  • EABA40000281 ()
  • EABA40000280 ()
400-0028

  • Chloride (Cl-) IVD, reagent
  • Total aspartate aminotransferase (AST) IVD, reagent
  • Glucose IVD, reagent
  • Total bilirubin IVD, reagent
  • Total protein IVD, reagent
  • Albumin IVD, reagent
  • Creatinine IVD, reagent
  • Urea IVD, reagent
  • Alanine aminotransferase (ALT) IVD, reagent
  • Total alkaline phosphatase (ALP) IVD, reagent
  • Calcium (Ca2+) IVD, reagent
  • Potassium (K+) IVD, reagent
  • Bicarbonate (HCO3-) IVD, reagent
  • Sodium (Na+) IVD, control
The Piccolo® Renal Function Panel, used with the Piccolo® blood chemistry analyzer or the PiccoloXpress® chemistry analyzer is intended to be used for the in vitro quantitative determination of albumin, calcium, chloride, creatinine, glucose, phosphorus, potassium, sodium, total carbon dioxide and blood urea nitrogen (BUN) in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used.
ABAXIS, INC.
400-0027
In Commercial Distribution

  • EABA40000271 ()
  • EABA40000270 ()
400-0027

  • Inorganic phosphate (PO43-) IVD, reagent
  • Chloride (Cl-) IVD, reagent
  • Sodium (Na+) IVD, control
  • Bicarbonate (HCO3-) IVD, reagent
  • Potassium (K+) IVD, reagent
  • Calcium (Ca2+) IVD, reagent
  • Urea IVD, reagent
  • Creatinine IVD, reagent
  • Albumin IVD, reagent
  • Glucose IVD, reagent
The Piccolo® Hepatic Function Panel, used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determinations of alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, direct bilirubin, total bilirubin, and total protein in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.
ABAXIS, INC.
400-0026
In Commercial Distribution

  • EABA40000261 ()
  • EABA40000260 ()
400-0026

  • Total alkaline phosphatase (ALP) IVD, reagent
  • Alanine aminotransferase (ALT) IVD, reagent
  • Conjugated (direct) bilirubin IVD, reagent
  • Albumin IVD, reagent
  • Total protein IVD, reagent
  • Total bilirubin IVD, reagent
  • Total aspartate aminotransferase (AST) IVD, reagent
The Piccolo® Basic Metabolic Panel, used with the Piccolo blood chemistry analyzer or the PiccoloXpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of calcium, chloride, creatinine, glucose, potassium, sodium, total carbon dioxide, and blood urea nitrogen (BUN) in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used.
ABAXIS, INC.
400-0024
In Commercial Distribution

  • EABA40000241 ()
  • EABA40000240 ()
400-0024

  • Chloride (Cl-) IVD, reagent
  • Sodium (Na+) IVD, control
  • Bicarbonate (HCO3-) IVD, reagent
  • Potassium (K+) IVD, reagent
  • Calcium (Ca2+) IVD, reagent
  • Urea IVD, reagent
  • Creatinine IVD, reagent
  • Glucose IVD, reagent
The Piccolo® MetLyte 8 Panel, used with the Piccolo® blood chemistry analyzer or the PiccoloXpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of chloride, creatine kinase, creatinine, glucose, potassium, sodium, total carbon dioxide and blood urea nitrogen (BUN) in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used.
ABAXIS, INC.
400-0023
In Commercial Distribution

  • EABA40000231 ()
  • EABA40000230 ()
400-0023

  • Chloride (Cl-) IVD, reagent
  • Sodium (Na+) IVD, control
  • Bicarbonate (HCO3-) IVD, reagent
  • Potassium (K+) IVD, reagent
  • Total creatine kinase (CK) IVD, reagent
  • Urea IVD, reagent
  • Creatinine IVD, reagent
  • Glucose IVD, reagent
The Piccolo® Liver Panel Plus, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, utilizes dry and liquid reagents to provide in vitro quantitative determinations of alanine aminotransferase, albumin, alkaline phosphatase, amylase, aspartate aminotransferase, gamma glutamyltransferase, total bilirubin, and total protein in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used.
ABAXIS, INC.
400-0003
In Commercial Distribution

  • EABA40000031 ()
  • EABA40000030 ()
400-0003

  • Gamma-glutamyltransferase (GGT) IVD, reagent
  • Total amylase IVD, reagent
  • Total alkaline phosphatase (ALP) IVD, reagent
  • Alanine aminotransferase (ALT) IVD, reagent
  • Total protein IVD, reagent
  • Total bilirubin IVD, reagent
  • Total aspartate aminotransferase (AST) IVD, reagent
  • Albumin IVD, reagent
No Description
CareRay Digital Medical Technology Co., Ltd.
YosemiteView 4343W
In Commercial Distribution

  • 06970597832022 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
CareRay Digital Medical Technology Co., Ltd.
YosemiteView 3643W
In Commercial Distribution

  • 06970597831049 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
CareRay Digital Medical Technology Co., Ltd.
EverestView 4343X
In Commercial Distribution

  • 06970597830752 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
CareRay Digital Medical Technology Co., Ltd.
CareView 1800Cwe
In Commercial Distribution

  • 06970597830745 ()


  • Portable basic diagnostic x-ray system, digital
No Description
CareRay Digital Medical Technology Co., Ltd.
CareView 1800Le
In Commercial Distribution

  • 06970597830721 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
CareRay Digital Medical Technology Co., Ltd.
CareView 3600RF
In Commercial Distribution

  • 06970597830479 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
CareRay Digital Medical Technology Co., Ltd.
CareView 750Cw
In Commercial Distribution

  • 06970597830363 ()


  • Portable basic diagnostic x-ray system, digital
No Description
CareRay Digital Medical Technology Co., Ltd.
CareView 750C
In Commercial Distribution

  • 06970597830349 ()


  • Portable basic diagnostic x-ray system, digital
No Description
CareRay Digital Medical Technology Co., Ltd.
CareView 1800RF
In Commercial Distribution

  • 06970597830271 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
CareRay Digital Medical Technology Co., Ltd.
CareView 1800Cw
In Commercial Distribution

  • 06970597830257 ()


  • Portable basic diagnostic x-ray system, digital
No Description
CareRay Digital Medical Technology Co., Ltd.
CareView 1800L
In Commercial Distribution

  • 06970597830240 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
CareRay Digital Medical Technology Co., Ltd.
CareView 1800R
In Commercial Distribution

  • 06970597830219 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
CareRay Digital Medical Technology Co., Ltd.
CareView 1500Cwe
In Commercial Distribution

  • 06970597830172 ()


  • Portable basic diagnostic x-ray system, digital
No Description
CareRay Digital Medical Technology Co., Ltd.
CareView 1500Cw
In Commercial Distribution

  • 06970597830097 ()


  • Portable basic diagnostic x-ray system, digital
No Description
CareRay Digital Medical Technology Co., Ltd.
CareView 1500L
In Commercial Distribution

  • 06970597830073 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
CareRay Digital Medical Technology Co., Ltd.
CareView 1500C
In Commercial Distribution

  • 06970597830066 ()


  • Portable basic diagnostic x-ray system, digital
No Description
CareRay Digital Medical Technology Co., Ltd.
CareView 1500P
In Commercial Distribution

  • 06970597830035 ()


  • Portable basic diagnostic x-ray system, digital
Pocguide Multi-Drug Test Panel (CLIA Waived), 14-Panel, 25T/Box; AMP1000/BAR300/BUP10/BZO300/COC300/EDDP300/MET1000/MDMA500/OPI2000/MTD300/OXY100/PCP25/TCA1000/THC50THC50
Hangzhou Aichek Medical Technology Co., Ltd.
1
In Commercial Distribution

  • 06978151200058 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Pocguide Multi-Drug Test Panel (CLIA Waived), 14-Panel, 25T/Box; AMP500/BAR300/BUP10/BZO300/COC150/EDDP300/MET500/MDMA500/MOP300/MTD300/OXY100/PCP25/TCA1000/THC50
Hangzhou Aichek Medical Technology Co., Ltd.
1
In Commercial Distribution

  • 06978151200034 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Pocguide Multi-Drug Test Panel (CLIA Waived), 12-Panel, 25T/Box; AMP500/BAR300/BUP10/BZO300/COC150/MET500/MDMA500/MTD300/MOP300/OXY100/PCP25/THC50
Hangzhou Aichek Medical Technology Co., Ltd.
1
In Commercial Distribution

  • 06978151200010 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500, THC50, COC150, MET500, MOR300, BZO300, OXY100, BAR300, BUP10, MDMA500, PCP25, MTD300, EDDP300, TCA1000, PPX300
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804830212 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Strips, including MOR2000
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804802646 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
15 strips, including MOR2000
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804802622 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
15 Strips, including MOR300
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804802608 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804801656 ()


  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
  • Methadone IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804801397 ()


  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
  • Methadone IVD, kit, rapid ICT, clinical
3CPM Company Electrogastrogram Research/Waterload platform Unit. Device uses ECG-like technology to capture the electrical waves of the stomach and intestines.
3CPM CO., INC.
2.09e
In Commercial Distribution

  • 00864359000223 ()


  • Myoelectric gastrointestinal motility analysis system
  • Electrocardiograph, professional, single-channel
No Description
ECHONOUS, INC.
R006025
In Commercial Distribution

  • 09353278000441 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
  • Electronic acoustic stethoscope
Extracorporeal ultrasound imaging system transducer, hand-held Electronic stethoscope
ECHONOUS, INC.
P006025
In Commercial Distribution

  • 09353278000137 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
  • Electronic acoustic stethoscope
A device supplying power to the flat panel sensor and connecting between the flat panel sensor and image processing unit.
FUJIFILM CORPORATION
DR-ID 1300 MP E
In Commercial Distribution

  • 04547410322934 ()


  • Stationary basic diagnostic x-ray system, digital
The Single Flat Panel Monitor, Light Head Single Flat Panel Monitor-G Series is used with the HarmonyAIR G-Series Suspension System.
STERIS CORPORATION
G-Series Suspension
Not in Commercial Distribution

  • 00724995166724 ()
10088703

  • Medical monitor/light mount
CD, Labpro V4.42 Panel Update-07 LabPro V4.42 Panel Update-07 Kit (US, OUS) LabPro V4.42 System Kit wPanel Update-07 (US,OUS)
Beckman Coulter, Inc.
V4.42
In Commercial Distribution

  • 15099590703110 ()
  • 15099590703271 ()
  • 15099590703127 ()


  • Microorganism identification/antimicrobial-susceptibility analyser IVD
The Verigene® Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene® System is a qualitative nucleic acid multiplex test intended to simultaneously detect and identify multiple respiratory virus nucleic acids in nasopharyngeal (NP) swab specimens from individuals with signs and symptoms of respiratory tract infection.
NANOSPHERE, INC.
20-011-020
Not in Commercial Distribution

  • 00857573006294 ()


  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
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