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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5 Panel with BZO, 300ng OPI
AMERICAN BIO MEDICA CORPORATION
10-5Z1-030
In Commercial Distribution

  • 10694644300458 ()
  • 10694644350453 ()
10-5Z1-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
5 PANEL W/METH,OXY, OPI300
AMERICAN BIO MEDICA CORPORATION
10-5MO1-030
In Commercial Distribution

  • 10694644300281 ()
  • 10694644350286 ()
10-5MO1-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
2 panel w/Coc & Meth Single
AMERICAN BIO MEDICA CORPORATION
10-2CM1-000
In Commercial Distribution

  • 10694644300083 ()
  • 10694644350088 ()
10-2CM1-000

  • Oxycodone IVD, calibrator
10 panel RAPIDTOX CUP II: AMP
AMERICAN BIO MEDICA CORPORATION
10-10XX2AB-030
In Commercial Distribution

  • 10694644200369 ()
  • 10694644250364 ()
10-10XX2AB-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
8 panel Rapid Tox opi 300
AMERICAN BIO MEDICA CORPORATION
10-8XT-030
In Commercial Distribution

  • 10694644100225 ()
  • 10694644150220 ()
10-8XT-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
10 Panel Rapid Tox opi 2000
AMERICAN BIO MEDICA CORPORATION
10-10XT-200
In Commercial Distribution

  • 10694644100041 ()
  • 10694644150046 ()
10-10XT-200

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
10 Panel Rapid Tox opi 300
AMERICAN BIO MEDICA CORPORATION
10-10XT-030
In Commercial Distribution

  • 10694644100034 ()
  • 10694644150039 ()
10-10XT-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
ECLIPSE WIDE BACK PANEL VQ GRAY
Vision Quest Industries Incorporated
40-11000-030
In Commercial Distribution

  • 00817717020340 ()


  • Cervical spine collar, reusable
MDMA Single Drug Urine Test Panel
Instant Technologies, Inc.
AWDMD-114
In Commercial Distribution

  • 00817405021123 ()
AWDMD-114

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Live View Panel Pro Version 2.0
Neurotronics, LLC
2.0
In Commercial Distribution

  • 00817111021264 ()


  • Sleep disorder interpretive software, professional-only
  • Bioelectrical signal analysis software
For use the MMR IHC Panel
Ventana Medical Systems, Inc.
790-5094
In Commercial Distribution

  • 07613336100592 ()
07862261001

  • Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent
  • Postmeiotic segregation increased 2 (PMS2) IVD, antibody
For use with MMR IHC Panel
Ventana Medical Systems, Inc.
790-5092
In Commercial Distribution

  • 07613336100578 ()
07862245001

  • Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent
  • MSH6 antigen IVD, antibody
DELTA 1.7MM PANEL 22X22 CTRSINKS X0.5MM
Stryker Leibinger GmbH & Co. KG
70-92052
In Commercial Distribution

  • 07613327090147 ()

  • Thickness: 0.5 Millimeter
  • 3D Plates: 22x22 Holes
70-92052

  • Craniofacial fixation plate, bioabsorbable
11 Panel Cup Drug Test, AMP-BAR-BZO-COC-MET500-MTD-OPI-OXY-PCP-TCA-THC
CLINICAL REFERENCE LABORATORY, INC.
51100
Not in Commercial Distribution

  • 81781502511007 ()
51100

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Assayed SA Nasal Complete Control Panel
MICROBIOLOGICS INC.
8196 Cepheid Xpert® SA Nasal Complete Control Panel
In Commercial Distribution

  • 70845357041233 ()
8196

  • MRSA/MSSA nucleic acid IVD, control
9 Panel Cup Drug Test, AMP-BAR-BZO-COC-MET-MTD-OPI-PCP-THC
CLINICAL REFERENCE LABORATORY, INC.
50900
Not in Commercial Distribution

  • 81781502509004 ()
50900

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 Panel Cup Drug Test, AMP-COC-MET-OPI-OXY-PCP-THC
CLINICAL REFERENCE LABORATORY, INC.
50701
Not in Commercial Distribution

  • 81781502507017 ()
50701

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 Panel Cup Drug Test, BAR-BZO-COC-MET-OPI-PCP-THC
CLINICAL REFERENCE LABORATORY, INC.
50700
Not in Commercial Distribution

  • 81781502507000 ()
50700

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Cup Drug Test, COC-MET-OPI-PCP-THC
CLINICAL REFERENCE LABORATORY, INC.
50500
Not in Commercial Distribution

  • 81781502505006 ()
50500

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
OneStep+ DOA Test Kit 10 Panel
HENRY SCHEIN, INC.
5701067
In Commercial Distribution

  • 10304040090289 ()
  • 00304040090282 ()
5701067

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
OneStep+ DOA Test Kit 14 Panel
HENRY SCHEIN, INC.
5701066
In Commercial Distribution

  • 10304040090302 ()
  • 00304040090305 ()
5701066

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
KIT, OPTIGEN US Panel Control Reagent
Minaris Medical America, Inc.
80109
In Commercial Distribution

  • 00813382010402 ()
80109

  • Allergen-specific/total immunoglobulin E (IgE) antibody IVD, control
5 Panel DOA Test clear Cup
Healgen Scientific Limited Liability Company
HCDOAEW-654
In Commercial Distribution

  • 20816490023740 ()
  • 10816490023743 ()
  • 00816490023746 ()
HCDOAEW-654

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel DOA Test clear Cup
Healgen Scientific Limited Liability Company
HCDOAEW-955
In Commercial Distribution

  • 20816490023726 ()
  • 10816490023729 ()
  • 00816490023722 ()
HCDOAEW-955

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test clear Cup
Healgen Scientific Limited Liability Company
HCDOAEW-6124
In Commercial Distribution

  • 20816490023467 ()
  • 10816490023460 ()
  • 00816490023463 ()
HCDOAEW-6124

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel DOA Test clear Cup
Healgen Scientific Limited Liability Company
HCDOAEW-4105
In Commercial Distribution

  • 20816490023450 ()
  • 10816490023453 ()
  • 00816490023456 ()
HCDOAEW-4105

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel DOA Test clear Cup
Healgen Scientific Limited Liability Company
HCDOAEW-8104
In Commercial Distribution

  • 20816490023382 ()
  • 10816490023385 ()
  • 00816490023388 ()
HCDOAEW-8104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
13 Panel DOA Test clear Cup
Healgen Scientific Limited Liability Company
HCDOAEW-2135
In Commercial Distribution

  • 20816490023344 ()
  • 10816490023347 ()
  • 00816490023340 ()
HCDOAEW-2135

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel DOA Test clear Cup
Healgen Scientific Limited Liability Company
HCDOAEW-8105
In Commercial Distribution

  • 20816490023092 ()
  • 10816490023095 ()
  • 00816490023098 ()
HCDOAEW-8105

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel DOA Test clear Cup
Healgen Scientific Limited Liability Company
DOAY-8104
In Commercial Distribution

  • 20816490023023 ()
  • 10816490023026 ()
  • 00816490023029 ()
DOAY-8104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel DOA Test clear Cup
Healgen Scientific Limited Liability Company
DOAY-654
In Commercial Distribution

  • 20816490023016 ()
  • 10816490023019 ()
  • 00816490023012 ()
DOAY-654

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test clear Cup
Healgen Scientific Limited Liability Company
DOAY-6125
In Commercial Distribution

  • 20816490022996 ()
  • 10816490022999 ()
  • 00816490022992 ()
DOAY-6125

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test clear Cup
Healgen Scientific Limited Liability Company
DOAY-6124
In Commercial Distribution

  • 20816490022972 ()
  • 10816490022975 ()
  • 00816490022978 ()
DOAY-6124

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 Panel DOA Test clear Cup
Healgen Scientific Limited Liability Company
DOAY-564
In Commercial Distribution

  • 20816490022965 ()
  • 10816490022968 ()
  • 00816490022961 ()
DOAY-564

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test clear Cup
Healgen Scientific Limited Liability Company
DOAY-5125
In Commercial Distribution

  • 20816490022958 ()
  • 10816490022951 ()
  • 00816490022954 ()
DOAY-5125

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel DOA Test clear Cup
Healgen Scientific Limited Liability Company
DOAY-4104
In Commercial Distribution

  • 20816490022934 ()
  • 10816490022937 ()
  • 00816490022930 ()
DOAY-4104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test clear Cup
Healgen Scientific Limited Liability Company
DOAY-3124
In Commercial Distribution

  • 20816490022927 ()
  • 10816490022920 ()
  • 00816490022923 ()
DOAY-3124

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test clear Cup
Healgen Scientific Limited Liability Company
HCDOAEC-6125
In Commercial Distribution

  • 20816490022453 ()
  • 10816490022456 ()
  • 00816490022459 ()
HCDOAEC-6125

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
8 Panel DOA Test clear Cup
Healgen Scientific Limited Liability Company
HCDOAEC-385
In Commercial Distribution

  • 20816490022446 ()
  • 10816490022449 ()
  • 00816490022442 ()
HCDOAEC-385

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CS 7600 SLOT PANEL SIZE 1-3
CARESTREAM HEALTH, INC.
CS 7600 SLOT PANEL
In Commercial Distribution

  • 60889971023704 ()
1023704

  • Dental computed radiography digital imaging scanner
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