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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 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

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 6 PANEL TEST - 00817830022672

Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / M-AMP / MTD / OPI / OXY
RAPID DIAGNOSTICS INC
07RD-7065-39
In Commercial Distribution

  • 00817830022672 ()

  • Length: 75 Millimeter
07RD-7065-39

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

DOA 7 PANEL TEST - 00817830022665

Immunoassay for the detection of the following drug substance(s) in human urine: BUP / BZD / COC / M-AMP / OPI / OXY / THC
RAPID DIAGNOSTICS INC
07RD-7070-15
In Commercial Distribution

  • 00817830022665 ()

  • Length: 75 Millimeter
07RD-7070-15

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

DOA 10 PANEL TEST - 00817830022658

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / COC / M-AMP / MTD / OPI / OXY / PCP / THC
RAPID DIAGNOSTICS INC
07RD-7073-04
In Commercial Distribution

  • 00817830022658 ()

  • Length: 75 Millimeter
07RD-7073-04

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

DOA 10 PANEL TEST - 00817830022252

Immunoassay for the detection of the following drug substance(s) in human urine: AMP/BAR/BUP/BZD/COC/M-AMP/MTD/OPI/OXY/THC
RAPID DIAGNOSTICS INC
07RD7073-03
In Commercial Distribution

  • 00817830022252 ()

  • Length: 75 Millimeter
07RD7073-03

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

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 10 PANEL TEST - 00817830022238

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

  • 00817830022238 ()

  • Length: 75 Millimeter
07RD7073-01

  • 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

DOA 9 PANEL TEST - 00817830022207

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

  • 00817830022207 ()

  • Length: 75 Millimeter
07RD7072-02

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

DOA 9 PANEL TEST - 00817830022191

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / COC / M-AMP / MTD / OPI-II/ PCP / THC
RAPID DIAGNOSTICS INC
07RD7072-01A
In Commercial Distribution

  • 00817830022191 ()

  • Length: 75 Millimeter
07RD7072-01A

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

DOA 9 PANEL TEST - 00817830022184

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / COC / M-AMP / MTD / OPI / PCP / THC
RAPID DIAGNOSTICS INC
07RD7072-01
In Commercial Distribution

  • 00817830022184 ()

  • Length: 75 Millimeter
07RD7072-01

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

DOA 8 PANEL TEST - 00817830022177

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / COC / MTD / OPI / OXY / THC
RAPID DIAGNOSTICS INC
07RD7071-12
In Commercial Distribution

  • 00817830022177 ()

  • Length: 75 Millimeter
07RD7071-12

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

DOA 8 PANEL TEST - 00817830022160

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BUP / BZD / COC / MTD / OPI / THC
RAPID DIAGNOSTICS INC
07RD7071-05
In Commercial Distribution

  • 00817830022160 ()

  • Length: 75 Millimeter
07RD7071-05

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

DOA 8 PANEL TEST - 00817830022153

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / COC / M-AMP / OPI-II/ PCP / THC
RAPID DIAGNOSTICS INC
07RD7071-04A
In Commercial Distribution

  • 00817830022153 ()

  • Length: 75 Millimeter
07RD7071-04A

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

DOA 8 PANEL TEST - 00817830022146

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / COC / M-AMP / OPI / PCP / THC
RAPID DIAGNOSTICS INC
07RD7071-04
In Commercial Distribution

  • 00817830022146 ()

  • Length: 75 Millimeter
07RD7071-04

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

DOA 8 PANEL TEST - 00817830022139

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / BUP / COC / M-AMP / MTD / OPI-II / THC
RAPID DIAGNOSTICS INC
07RD7071-03A
In Commercial Distribution

  • 00817830022139 ()

  • Length: 75 Millimeter
07RD7071-03A

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

DOA 8 PANEL TEST - 00817830022122

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / BUP / COC / M-AMP / MTD / OPI / THC
RAPID DIAGNOSTICS INC
07RD7071-03
In Commercial Distribution

  • 00817830022122 ()

  • Length: 75 Millimeter
07RD7071-03

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

DOA 8 PANEL TEST - 00817830022115

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / COC / M-AMP / MTD / OPI-II/ PCP / THC
RAPID DIAGNOSTICS INC
07RD7071-02A
In Commercial Distribution

  • 00817830022115 ()

  • Length: 75 Millimeter
07RD7071-02A

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

DOA 8 PANEL TEST - 00817830022108

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / COC / M-AMP / MTD / OPI / PCP / THC
RAPID DIAGNOSTICS INC
07RD7071-02
In Commercial Distribution

  • 00817830022108 ()

  • Length: 75 Millimeter
07RD7071-02

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

DOA 8 PANEL TEST - 00817830022092

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / COC / M-AMP / MTD / OPI-II/ THC
RAPID DIAGNOSTICS INC
07RD7071-01A
In Commercial Distribution

  • 00817830022092 ()

  • Length: 75 Millimeter
07RD7071-01A

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

DOA 8 PANEL TEST - 00817830022085

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / COC / M-AMP / MTD / OPI / THC
RAPID DIAGNOSTICS INC
07RD7071-01
In Commercial Distribution

  • 00817830022085 ()

  • Length: 75 Millimeter
07RD7071-01

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

DOA 7 PANEL TEST - 00817830022078

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / COC / M-AMP / PCP / THC
RAPID DIAGNOSTICS INC
07RD7070-08
In Commercial Distribution

  • 00817830022078 ()

  • Length: 75 Millimeter
07RD7070-08

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

DOA 7 PANEL TEST - 00817830022061

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / COC / M-AMP / MTD / OPI / OXY
RAPID DIAGNOSTICS INC
07RD7070-07
In Commercial Distribution

  • 00817830022061 ()

  • Length: 75 Millimeter
07RD7070-07

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

DOA 7 PANEL TEST - 00817830022054

Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / M-AMP / MTD / OPI / OXY / THC
RAPID DIAGNOSTICS INC
07RD7070-06
In Commercial Distribution

  • 00817830022054 ()

  • Length: 75 Millimeter
07RD7070-06

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

DOA 7 PANEL TEST - 00817830022047

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / COC / MTD / OPI-II/ THC
RAPID DIAGNOSTICS INC
07RD7070-05A
In Commercial Distribution

  • 00817830022047 ()

  • Length: 75 Millimeter
07RD7070-05A

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