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® 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
Thomas Hilfen für Körperbehinderte GmbH & Co. Medico Kommanditgesellschaft
9800066355000
In Commercial Distribution

  • 04034089053752 ()


  • Assistive pushchair
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
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
No Description
QIAGEN GmbH
V1
Not in Commercial Distribution

  • 04053228033905 ()
691221

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Bird & Cronin, LLC
0818ABB4P96
In Commercial Distribution

  • 00610570167692 ()
  • 00610570158812 ()


  • Abdominal binder, single-use
No Description
Bird & Cronin, LLC
0818ABB4P72
In Commercial Distribution

  • 00610570167685 ()
  • 00610570158805 ()


  • Abdominal binder, single-use
No Description
Bird & Cronin, LLC
0818ABB4P62
In Commercial Distribution

  • 00610570167678 ()
  • 00610570158799 ()


  • Abdominal binder, single-use
No Description
Bird & Cronin, LLC
0818ABB4P45
In Commercial Distribution

  • 00610570167661 ()
  • 00610570158782 ()


  • Abdominal binder, single-use
No Description
Bird & Cronin, LLC
0818ABB3P72
In Commercial Distribution

  • 00610570167654 ()
  • 00610570158775 ()


  • Abdominal binder, single-use
No Description
Bird & Cronin, LLC
0818ABB3P62
In Commercial Distribution

  • 00610570167647 ()
  • 00610570158768 ()


  • Abdominal binder, single-use
No Description
Bird & Cronin, LLC
0818ABB3P45
In Commercial Distribution

  • 00610570167623 ()
  • 00610570158751 ()


  • Abdominal binder, single-use
The ATLAS Headbox Expansion Panel is an accessory to the ATLAS Neurophysiology System and ATLAS Stim Headbox. The HEP is a power module and a signal splitter.
NEURALYNX, INC.
ATLAS HEP
In Commercial Distribution

  • 00850011306512 ()
31-0607-0014

  • Electroencephalographic signal amplifier
  • Somatosensory electrical stimulation system
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
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
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)
The Praxis™ Extended RAS Panel assay is designed specifically for the detection of 56 mutations from exons 2, 3, and 4 of the KRAS and NRAS genes using the Illumina MiSeqDx Instrument. The assay has been configured for 2 runs with a maximum of 10 samples plus 2 controls per run. Illumina provides the following reagents for the Illumina Praxis Extended RAS Panel: 20012195, Praxis Extended RAS Panel – 1/6; 20012196, Praxis Extended RAS Panel – 1A; 20012197, Praxis Extended RAS Panel – 1B; 20012198, Praxis Extended RAS Panel – 2/6; 20012199, Praxis Extended RAS Panel – 3/6; 20012200, Praxis Extended RAS Panel – 3A; 20012201, Praxis Extended RAS Panel – 3B; 20012202, Praxis Extended RAS Panel – 4/6; 20012203, Praxis Extended RAS Panel – 5/6; and 20012204, Praxis Extended RAS Panel – 6/6.
ILLUMINA, INC.
20012431
Not in Commercial Distribution

  • 00816270020088 ()
20012431

  • Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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