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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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Piccolo MetLac 12 Panel - EABA40000371

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

Piccolo Lipid Panel Plus - EABA40000301

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

Piccolo Comprehensive Metabolic Panel - EABA40000281

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

Piccolo Renal Function Panel - EABA40000271

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

Piccolo Hepatic Function Panel - EABA40000261

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

Piccolo Basic Metabolic Panel - EABA40000241

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

Piccolo MetLyte 8 Panel - EABA40000231

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

Piccolo Liver Panel Plus - EABA40000031

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

MULTI-DRUG SCREEN TEST PANEL - 10815845021083

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

Calf panel size 1 - 04034089053752

No Description
Thomas Hilfen für Körperbehinderte GmbH & Co. Medico Kommanditgesellschaft
9800066355000
In Commercial Distribution

  • 04034089053752 ()


  • Assistive pushchair

FilmArray® BCID Panel - 00815381020093

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

FilmArray® BCID Panel - 00815381020086

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

Head and Neck Panel - B365512500

No Description
Aktina Corp.
51-250
In Commercial Distribution

  • B365512500 ()


  • Indexed-immobilization patient positioning system

IGRT Oblique Treatment Panel - B365112170

No Description
Aktina Corp.
11-217
In Commercial Distribution

  • B365112170 ()


  • Radiological whole-body positioner

C-Arm Solid Panel Insert - B365112110

No Description
Aktina Corp.
11-211
In Commercial Distribution

  • B365112110 ()


  • Radiological whole-body positioner

URINE BROAD PANEL HIGH - B30001346000010

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

PM PANEL COMBO V9 - B80002942500010

No Description
UTAK LABORATORIES, INC.
PM PAN COM V9
In Commercial Distribution

  • B80002942500010 ()
  • B80002942500011 ()
  • B80002942500012 ()
  • B80002942500013 ()
  • B80002942500016 ()
  • B80002942500017 ()
  • B80002942500018 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

DOA 10 PANEL TEST - 00817830022245

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BUP / BZD / COC / M-AMP / MTD / OPI-II/ PCP / THC
RAPID DIAGNOSTICS INC
07RD7073-01A
In Commercial Distribution

  • 00817830022245 ()

  • Length: 75 Millimeter
07RD7073-01A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

DOA 9 PANEL TEST - 00817830022221

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BUP / BZD / COC / MTD / OPI / OXY / THC
RAPID DIAGNOSTICS INC
07RD7072-06
In Commercial Distribution

  • 00817830022221 ()

  • Length: 75 Millimeter
07RD7072-06

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

DOA 9 PANEL TEST - 00817830022214

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / BUP / COC / M-AMP / MTD / OPI-II / THC
RAPID DIAGNOSTICS INC
07RD7072-02A
In Commercial Distribution

  • 00817830022214 ()

  • Length: 75 Millimeter
07RD7072-02A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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