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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In-vitro multiplex assay used with the Biocode MDx 3000 for the detection of gastrointestinal pathogens.
APPLIED BIOCODE, INC.
1
In Commercial Distribution

  • 00851034007011 ()


  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
S8377 Cleaning MET II Solution membrane bottle , 6*100mL for ABL8XX
Radiometer Medical ApS
944-136
In Commercial Distribution

  • 15700699441369 ()
  • 05700699441362 ()
944-136

  • Wash/cleaning solution IVD, automated/semi-automated system
S1827 Crea Calibration Solution 1, membrane bottle, 6x175 mL, for ABL8XX, USA
Radiometer Medical ApS
944-135
In Commercial Distribution

  • 15700699441352 ()
  • 05700699441355 ()
944-135

  • Multiple blood gas analyte IVD, calibrator
S1837 Crea Calibration Solution 2, membrane bottle, 6x140 mL, for ABL8XX
Radiometer Medical ApS
944-134
In Commercial Distribution

  • 15700699441345 ()
  • 05700699441348 ()
944-134

  • Multiple blood gas analyte IVD, calibrator
S1827 Crea Calibration Solution 1, membrane bottle, 6x175 mL, for ABL8XX, JAP/ROW
Radiometer Medical ApS
944-133
In Commercial Distribution

  • 15700699441338 ()
  • 05700699441331 ()
944-133

  • Multiple blood gas analyte IVD, calibrator
S7375 Cleaning Solution 175mL for ABL7XX
Radiometer Medical ApS
944-123
Not in Commercial Distribution

  • 05700699441232 ()
944-123

  • Wash/cleaning solution IVD, automated/semi-automated system
S7865 AutoCheck 6+, level 4 box of 30 ampoules, for ABL8XX
Radiometer Medical ApS
944-097
In Commercial Distribution

  • 55700699440971 ()
  • 05700699440976 ()
944-097

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
S7855 AutoCheck 6+, level 3 box of 30 ampoules, for ABL8XX
Radiometer Medical ApS
944-096
In Commercial Distribution

  • 55700699440964 ()
  • 05700699440969 ()
944-096

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
S7845 AutoCheck 6+, level 2 box of 30 ampoules, for ABL8XX
Radiometer Medical ApS
944-095
In Commercial Distribution

  • 55700699440957 ()
  • 05700699440952 ()
944-095

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
S7835 AutoCheck 6+, level 1 box of 30 ampoules, for ABL8XX
Radiometer Medical ApS
944-094
In Commercial Distribution

  • 55700699440940 ()
  • 05700699440945 ()
944-094

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
D8088+D8089 Crea membrane box A+B, with 2xA and 2xB membrane units, for ABL8XX
Radiometer Medical ApS
942-073
In Commercial Distribution

  • 05700699420732 ()
942-073

  • Creatinine IVD, reagent
D7077 Lac membrane box (4 units) for ABL7XX/8XX
Radiometer Medical ApS
942-066
In Commercial Distribution

  • 05700699420664 ()
  • 55700699420669 ()
942-066

  • Lactate electrode IVD
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
993-35191
In Commercial Distribution

  • 04987481164635 ()
  • 14987481164632 ()
993-35191

  • Non-esterified fatty acid IVD, reagent
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
991-34891
In Commercial Distribution

  • 04987481164628 ()
  • 14987481164625 ()
991-34891

  • Non-esterified fatty acid IVD, reagent
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
995-34791
In Commercial Distribution

  • 04987481164611 ()
  • 14987481164618 ()
995-34791

  • Non-esterified fatty acid IVD, reagent
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
999-34691
In Commercial Distribution

  • 04987481164604 ()
  • 14987481164601 ()
999-34691

  • Non-esterified fatty acid IVD, reagent
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
990-28011
In Commercial Distribution

  • 04987481164550 ()
  • 14987481164557 ()
  • 10856626006035 ()
990-28011

  • High density lipoprotein (HDL) cholesterol IVD, calibrator
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
999-00504
In Commercial Distribution

  • 04987481164543 ()
  • 14987481164540 ()
999-00504

  • Low density lipoprotein (LDL) cholesterol IVD, reagent
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
999-00404
In Commercial Distribution

  • 04987481164536 ()
  • 14987481164533 ()
999-00404

  • Low density lipoprotein (LDL) cholesterol IVD, reagent
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
991-61401
In Commercial Distribution

  • 04987481164499 ()
  • 14987481164496 ()
  • 10856626006066 ()
991-61401

  • Des-gamma-carboxyprothrombin (DCP) IVD, control
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
995-61301
In Commercial Distribution

  • 04987481164482 ()
  • 14987481164489 ()
  • 10856626006134 ()
995-61301

  • Des-gamma-carboxyprothrombin (DCP) IVD, control
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
997-61501
In Commercial Distribution

  • 04987481164468 ()
  • 14987481164465 ()
  • 10856626006189 ()
997-61501

  • Alpha-fetoprotein-L3 fraction (AFP-L3) IVD, kit, fluorescent immunoassay
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
993-61101
In Commercial Distribution

  • 04987481164451 ()
  • 14987481164458 ()
  • 10856626006073 ()
993-61101

  • Alpha-fetoprotein-L3 fraction (AFP-L3) IVD, control
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
997-61001
In Commercial Distribution

  • 04987481164444 ()
  • 14987481164441 ()
  • 10856626006172 ()
997-61001

  • Alpha-fetoprotein-L3 fraction (AFP-L3) IVD, control
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
464-01601
In Commercial Distribution

  • 04987481102927 ()
  • 14987481102924 ()
  • 10856626006028 ()
464-01601

  • Triglyceride IVD, calibrator
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
276-76491
In Commercial Distribution

  • 04987481100992 ()
  • 14987481100999 ()
  • 10856626006011 ()
276-76491

  • Non-esterified fatty acid IVD, calibrator
No Description
DIASORIN MOLECULAR LLC
MOL9207
In Commercial Distribution

  • 10816101027313 ()
MOL9207

  • Assay development analyte-specific reagent IVD
No Description
DIASORIN MOLECULAR LLC
MOL9203
In Commercial Distribution

  • 10816101027306 ()
MOL9203

  • Assay development analyte-specific reagent IVD
No Description
DIASORIN MOLECULAR LLC
MOL9178
In Commercial Distribution

  • 10816101027290 ()
MOL9178

  • Assay development analyte-specific reagent IVD
No Description
DIASORIN MOLECULAR LLC
MOL9202
In Commercial Distribution

  • 10816101027283 ()
MOL9202

  • Assay development analyte-specific reagent IVD
No Description
DIASORIN MOLECULAR LLC
MOL9773
In Commercial Distribution

  • 10816101027221 ()
MOL9773

  • Assay development analyte-specific reagent IVD
No Description
DIASORIN MOLECULAR LLC
MOL9771
In Commercial Distribution

  • 10816101027207 ()
MOL9771

  • Assay development analyte-specific reagent IVD
No Description
Vista Dental
803801-16
In Commercial Distribution

  • 10818207024418 ()


  • Root canal cleaning solution
No Description
Vista Dental
803802-16
In Commercial Distribution

  • 10818207024401 ()


  • Root canal cleaning solution
No Description
Vista Dental
6000000
In Commercial Distribution

  • 10818207024388 ()


  • Endodontic lavage system
No Description
Vista Dental
6000001
In Commercial Distribution

  • 10818207024371 ()


  • Endodontic lavage system
No Description
Vista Dental
6000002
In Commercial Distribution

  • 10818207024364 ()


  • Endodontic lavage system
No Description
Vista Dental
803803-16
In Commercial Distribution

  • 10818207024357 ()


  • Root canal cleaning solution
No Description
Roche Diagnostics GmbH
20766399122
In Commercial Distribution

  • 04015630915644 ()
20766399122

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator
No Description
Roche Diagnostics GmbH
20766305122
In Commercial Distribution

  • 04015630915637 ()
20766305122

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator
Dental Whitening Agent
Cavex Holland B.V.
BW090
In Commercial Distribution

  • E241BW0900 ()

  • 1 pcs
BW090

  • Dental bleaching agent
Dental Whitening Agent
Cavex Holland B.V.
BW035
In Commercial Distribution

  • E241BW0350 ()

  • 1 pcs
BW035

  • Dental bleaching agent
Dental Whitening Agent
Cavex Holland B.V.
BW030
In Commercial Distribution

  • E241BW0300 ()

  • 1 pcs
BW030

  • Dental bleaching agent
Dental Whitening Agent
Cavex Holland B.V.
BW015
In Commercial Distribution

  • E241BW0150 ()

  • 1 pcs
BW015

  • Dental bleaching agent
Dental Whitening Agent
Cavex Holland B.V.
BW010
In Commercial Distribution

  • E241BW0100 ()

  • 1 pcs
BW010

  • Dental bleaching agent
Dental Whitening Agent
Cavex Holland B.V.
BW000
In Commercial Distribution

  • E241BW0000 ()

  • 1 pcs
BW000

  • Dental bleaching agent
Refrigeration Test Yolk Buffer with Gentamicin
FUJIFILM IRVINE SCIENTIFIC, INC.
90129-20x5mL
In Commercial Distribution

  • 00893727002866 ()
  • 10893727002863 ()

  • Total Volume: 5 Milliliter
90129

  • IVF medium
No Description
FUJIFILM IRVINE SCIENTIFIC, INC.
T105-500mL
In Commercial Distribution

  • 00893727002774 ()

  • Total Volume: 500 Milliliter
T105

  • Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent
Chang Medium in SITU
FUJIFILM IRVINE SCIENTIFIC, INC.
T104-500ML
In Commercial Distribution

  • 00893727002767 ()

  • Total Volume: 500 Milliliter
T104

  • Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent
No Description
FUJIFILM IRVINE SCIENTIFIC, INC.
99473-500ML
In Commercial Distribution

  • 00893727002699 ()

  • Total Volume: 500 Milliliter
99473

  • Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent
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