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

Show Filters

Immunoassay for the detection of the following drug substance(s) in human urine: BUP / MTD / OPI-II
RAPID DIAGNOSTICS INC
07RD7062-11A
In Commercial Distribution

  • 00817830020937 ()

  • Length: 75 Millimeter
07RD7062-11A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BUP / MTD / OPI
RAPID DIAGNOSTICS INC
07RD7062-11
In Commercial Distribution

  • 00817830020920 ()

  • Length: 75 Millimeter
07RD7062-11

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BUP / BZD / OPI-II
RAPID DIAGNOSTICS INC
07RD7062-10A
In Commercial Distribution

  • 00817830020913 ()

  • Length: 75 Millimeter
07RD7062-10A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BUP / BZD / OPI
RAPID DIAGNOSTICS INC
07RD7062-10
In Commercial Distribution

  • 00817830020906 ()

  • Length: 75 Millimeter
07RD7062-10

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BUP / M-AMP
RAPID DIAGNOSTICS INC
07RD7062-09
In Commercial Distribution

  • 00817830020890 ()

  • Length: 75 Millimeter
07RD7062-09

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / MTD
RAPID DIAGNOSTICS INC
07RD7062-08
In Commercial Distribution

  • 00817830020883 ()

  • Length: 75 Millimeter
07RD7062-08

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / THC
RAPID DIAGNOSTICS INC
07RD7062-07
In Commercial Distribution

  • 00817830020876 ()

  • Length: 75 Millimeter
07RD7062-07

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BZD / MTD / OPI-II
RAPID DIAGNOSTICS INC
07RD7062-06A
In Commercial Distribution

  • 00817830020869 ()

  • Length: 75 Millimeter
07RD7062-06A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BZD / MTD / OPI
RAPID DIAGNOSTICS INC
07RD7062-06
In Commercial Distribution

  • 00817830020852 ()

  • Length: 75 Millimeter
07RD7062-06

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / OPI-II
RAPID DIAGNOSTICS INC
07RD7062-05A
In Commercial Distribution

  • 00817830020845 ()

  • Length: 75 Millimeter
07RD7062-05A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / OPI
RAPID DIAGNOSTICS INC
07RD7062-05
In Commercial Distribution

  • 00817830020838 ()

  • Length: 75 Millimeter
07RD7062-05

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: COC / OPI-II / THC
RAPID DIAGNOSTICS INC
07RD7062-04A
In Commercial Distribution

  • 00817830020821 ()

  • Length: 75 Millimeter
07RD7062-04A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: COC / OPI / THC
RAPID DIAGNOSTICS INC
07RD7062-04
In Commercial Distribution

  • 00817830020814 ()

  • Length: 75 Millimeter
07RD7062-04

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: M-AMP / OPI-II / THC
RAPID DIAGNOSTICS INC
07RD7062-03A
In Commercial Distribution

  • 00817830020807 ()

  • Length: 75 Millimeter
07RD7062-03A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: M-AMP / OPI / THC
RAPID DIAGNOSTICS INC
07RD7062-03
In Commercial Distribution

  • 00817830020791 ()

  • Length: 75 Millimeter
07RD7062-03

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: COC / M-AMP / THC
RAPID DIAGNOSTICS INC
07RD7062-02
In Commercial Distribution

  • 00817830020784 ()

  • Length: 75 Millimeter
07RD7062-02

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / THC
RAPID DIAGNOSTICS INC
07RD7062-01
In Commercial Distribution

  • 00817830020777 ()

  • Length: 75 Millimeter
07RD7062-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BUP
RAPID DIAGNOSTICS INC
07RD7060-11
In Commercial Distribution

  • 00817830020760 ()

  • Length: 75 Millimeter
07RD7060-11

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: THC
RAPID DIAGNOSTICS INC
07RD7060-10
In Commercial Distribution

  • 00817830020753 ()

  • Length: 75 Millimeter
07RD7060-10

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: PCP
RAPID DIAGNOSTICS INC
07RD7060-09
In Commercial Distribution

  • 00817830020746 ()

  • Length: 75 Millimeter
07RD7060-09

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: OXY
RAPID DIAGNOSTICS INC
07RD7060-08
In Commercial Distribution

  • 00817830020739 ()

  • Length: 75 Millimeter
07RD7060-08

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: OPI-II
RAPID DIAGNOSTICS INC
07RD7060-07A
In Commercial Distribution

  • 00817830020722 ()

  • Length: 75 Millimeter
07RD7060-07A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: OPI
RAPID DIAGNOSTICS INC
07RD7060-07
In Commercial Distribution

  • 00817830020715 ()

  • Length: 75 Millimeter
07RD7060-07

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: MTD
RAPID DIAGNOSTICS INC
07RD7060-06
In Commercial Distribution

  • 00817830020708 ()

  • Length: 75 Millimeter
07RD7060-06

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: M-AMP
RAPID DIAGNOSTICS INC
07RD7060-05
In Commercial Distribution

  • 00817830020692 ()

  • Length: 75 Millimeter
07RD7060-05

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BZD
RAPID DIAGNOSTICS INC
07RD7060-03
In Commercial Distribution

  • 00817830020678 ()

  • Length: 75 Millimeter
07RD7060-03

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
One Step Drug Screen Test Card (COC300/AMP1000/mAMP1000/MOP300)
ALERE SAN DIEGO, INC.
DOA-144-1351
In Commercial Distribution

  • 10815845021083 ()
4588760099

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
No Description
Thomas Hilfen für Körperbehinderte GmbH & Co. Medico Kommanditgesellschaft
9800066355000
In Commercial Distribution

  • 04034089053752 ()


  • Assistive pushchair
No Description
Carl Zeiss Meditec AG
Model II
In Commercial Distribution

  • 04049539103512 ()


  • Desktop computer
No Description
Carl Zeiss Meditec AG
Model III
In Commercial Distribution

  • 04049539069214 ()


  • Desktop computer
Stool Bacterial Pathogens Panel Cartridge with sample prep device.
GREAT BASIN SCIENTIFIC, INC.
GBSBPP-10
In Commercial Distribution

  • B178SBPP102 ()
  • B178GBSBPP100 ()
GBSBPP-10

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray
  • Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
UTAK LABORATORIES, INC.
UBP H F V DU
In Commercial Distribution

  • B30001346000010 ()
  • B30001346000011 ()
  • B30001346000012 ()
  • B30001346000013 ()
  • B30001346000016 ()
  • B30001346000017 ()
  • B30001346000018 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control
IVD reagent kit containing 6 tests.
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0127
Not in Commercial Distribution

  • 00815381020093 ()
RFIT-ASY-0127

  • Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry
IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0126
Not in Commercial Distribution

  • 00815381020086 ()
RFIT-ASY-0126

  • Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry
Detection of Syphilis, 10 samples
ARLINGTON SCIENTIFIC, INC.
NC-907000
In Commercial Distribution

  • 00816057020980 ()

  • Total Volume: 0.5 Milliliter
NC-907000

  • Treponema pallidum reagin antibody IVD, kit, agglutination
No Description
Aktina Corp.
11-217
In Commercial Distribution

  • B365112170 ()


  • Radiological whole-body positioner
No Description
Aktina Corp.
11-211
In Commercial Distribution

  • B365112110 ()


  • Radiological whole-body positioner
No Description
Aktina Corp.
51-250
In Commercial Distribution

  • B365512500 ()


  • Indexed-immobilization patient positioning system
The Piccolo® MetLac 12 Panel reagent disc, used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of albumin, calcium, chloride, creatinine, glucose, lactate, magnesium, phosphorus, potassium, sodium, total carbon dioxide and blood urea nitrogen (BUN) in lithium heparinized whole blood or lithium heparinized plasma in a clinical laboratory setting or point-of-care location.
ABAXIS, INC.
400-0037
In Commercial Distribution

  • EABA40000371 ()
  • EABA40000370 ()
400-0037

  • Lactate IVD, reagent
  • Magnesium (Mg2+) IVD, reagent
  • 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® BioChemistry Panel Plus, used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), amylase, aspartate aminotransferase (AST), c-reactive protein (CRP), calcium, creatinine, gamma glutamyltransferase (GGT), glucose, total protein, blood urea nitrogen (BUN), and uric acid in lithium heparinized whole blood, lithium heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. The Abaxis CRP method is not intended for high sensitivity CRP measurement.
ABAXIS, INC.
400-0035
In Commercial Distribution

  • EABA40000351 ()
  • EABA40000350 ()
400-0035

  • Total aspartate aminotransferase (AST) IVD, reagent
  • Glucose IVD, reagent
  • Total protein IVD, reagent
  • Uric acid IVD, reagent
  • Albumin IVD, reagent
  • Creatinine IVD, reagent
  • Urea IVD, reagent
  • Alanine aminotransferase (ALT) IVD, reagent
  • Total alkaline phosphatase (ALP) IVD, reagent
  • Total amylase IVD, reagent
  • Calcium (Ca2+) IVD, reagent
  • Gamma-glutamyltransferase (GGT) IVD, reagent
  • C-reactive protein (CRP) IVD, reagent
< 1 ... 122 123 124 125 126 ... 234 >