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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 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

Calf panel size 1 - 04034089053752

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

  • 04034089053752 ()


  • Assistive pushchair

CALLISTO eye Panel PC - 04049539103512

No Description
Carl Zeiss Meditec AG
Model II
In Commercial Distribution

  • 04049539103512 ()


  • Desktop computer

CALLISTO eye Panel PC - 04049539069214

No Description
Carl Zeiss Meditec AG
Model III
In Commercial Distribution

  • 04049539069214 ()


  • Desktop computer

ASI Syphilis Reference Panel - 00816057020980

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

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
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