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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HIV-1 Analytical Measurement Range Panel
EXACT DIAGNOSTICS, LLC
HIVAMR
In Commercial Distribution

  • 00812242030208 ()
HIVAMR

  • HIV1 nucleic acid IVD, calibrator
DELTA 1.7MM PANEL 22X22 CTRSINKSX0.75MM
Stryker Leibinger GmbH & Co. KG
70-92053
In Commercial Distribution

  • 07613327090185 ()

  • 3D Plates: 22x22 Holes
  • Thickness: 0.75 Millimeter
70-92053

  • Craniofacial fixation plate, bioabsorbable
Assayed MRSA NxG Control Panel
MICROBIOLOGICS INC.
8195 Cepheid Xpert® MRSA NxG Control Panel
In Commercial Distribution

  • 70845357041226 ()
8195

  • MRSA nucleic acid IVD, control
Assayed GBS LB Control Panel
MICROBIOLOGICS INC.
8194 Cepheid Xpert® GBS LB Control Panel
Not in Commercial Distribution

  • 70845357041219 ()
8194

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, control
Assayed CT/NG Control Panel
MICROBIOLOGICS INC.
8188 Cepheid Xpert® CT/NG Control Panel
In Commercial Distribution

  • 70845357041189 ()
8188

  • Multiple-type sexually transmitted pathogen nucleic acid IVD, control
TABLE POST WITHOUT PANEL BOX
Surgipros, LLC
50-4581SP
In Commercial Distribution

  • 00810143900866 ()


  • Surgical retraction system mounting frame, reusable
KIT, OPTIGEN Universal Panel 20
Minaris Medical America, Inc.
85003
Not in Commercial Distribution

  • 00813382010075 ()
85003

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
KIT, OPTIGEN Universal Panel 20
Minaris Medical America, Inc.
85003
In Commercial Distribution

  • 00813382010006 ()
85003

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
Single Panel DOA Test Dipcard
Healgen Scientific Limited Liability Company
HDMD-101
In Commercial Distribution

  • 20816490023863 ()
  • 10816490023866 ()
  • 00816490023869 ()
HDMD-101

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 Panel DOA Test Dipcard
Healgen Scientific Limited Liability Company
HDOA-1164
In Commercial Distribution

  • 20816490023849 ()
  • 10816490023842 ()
  • 00816490023845 ()
HDOA-1164

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 Panel DOA Test Dipcard
Healgen Scientific Limited Liability Company
HDOA-1864
In Commercial Distribution

  • 20816490023634 ()
  • 10816490023637 ()
  • 00816490023630 ()
HDOA-1864

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Single Panel DOA Test Strip
Healgen Scientific Limited Liability Company
GBTHC-101a
In Commercial Distribution

  • 20816490023542 ()
  • 10816490023545 ()
  • 00816490023548 ()
GBTHC-101a

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Single Panel DOA Test Strip
Healgen Scientific Limited Liability Company
GBOPI-101a
In Commercial Distribution

  • 20816490023535 ()
  • 10816490023538 ()
  • 00816490023531 ()
GBOPI-101a

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
3 Panel DOA Test Dipcard
Healgen Scientific Limited Liability Company
HDOA-535
In Commercial Distribution

  • 20816490023436 ()
  • 10816490023439 ()
  • 00816490023432 ()
HDOA-535

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel DOA Test Dipcard
Healgen Scientific Limited Liability Company
HDOA-1454
In Commercial Distribution

  • 20816490023115 ()
  • 10816490023118 ()
  • 00816490023111 ()
HDOA-1454

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 Panel DOA Test Dipcard
Healgen Scientific Limited Liability Company
HDOA-1575
In Commercial Distribution

  • 20816490023047 ()
  • 10816490023040 ()
  • 00816490023043 ()
HDOA-1575

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test Cup
Healgen Scientific Limited Liability Company
DOAY-4124
In Commercial Distribution

  • 20816490022941 ()
  • 10816490022944 ()
  • 00816490022947 ()
DOAY-4124

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel DOA Test Cup;
Healgen Scientific Limited Liability Company
DOAY-3104
In Commercial Distribution

  • 20816490022910 ()
  • 10816490022913 ()
  • 00816490022916 ()
DOAY-3104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 Panel DOA Test Cup
Healgen Scientific Limited Liability Company
DOAY-264
In Commercial Distribution

  • 20816490022897 ()
  • 10816490022890 ()
  • 00816490022893 ()
DOAY-264

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

  • 20816490022873 ()
  • 10816490022876 ()
  • 00816490022879 ()
DOAY-2135

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
14 Panel DOA Test Dipcard
Healgen Scientific Limited Liability Company
HDOA-1145
In Commercial Distribution

  • 20816490022835 ()
  • 10816490022838 ()
  • 00816490022831 ()
HDOA-1145

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

  • 20816490022811 ()
  • 10816490022814 ()
  • 00816490022817 ()
HDOA-2135

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel DOA Test Dipcard
Healgen Scientific Limited Liability Company
HDOA-11105
In Commercial Distribution

  • 20816490022309 ()
  • 10816490022302 ()
  • 00816490022305 ()
HDOA-11105

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 Panel DOA Test Dipcard
Healgen Scientific Limited Liability Company
HDOA-975
In Commercial Distribution

  • 20816490021777 ()
  • 10816490021770 ()
  • 00816490021773 ()
HDOA-975

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
11 Panel DOA Test Dipcard
Healgen Scientific Limited Liability Company
HDOA-6114
In Commercial Distribution

  • 20816490021760 ()
  • 10816490021763 ()
  • 00816490021766 ()
HDOA-6114

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test Dipcard
Healgen Scientific Limited Liability Company
HDOA-10125
In Commercial Distribution

  • 20816490021715 ()
  • 10816490021718 ()
  • 00816490021711 ()
HDOA-10125

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 Panel DOA Test Dipcard
Healgen Scientific Limited Liability Company
HDOA-675H
In Commercial Distribution

  • 20816490021708 ()
  • 10816490021701 ()
  • 00816490021704 ()
HDOA-675H

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Single Panel DOA Test Dipcard
Healgen Scientific Limited Liability Company
HDED-114
In Commercial Distribution

  • 20816490021609 ()
  • 10816490021602 ()
  • 00816490021605 ()
HDED-114

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

  • 20816490021562 ()
  • 10816490021565 ()
  • 00816490021568 ()
HDOA-8104

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

  • 20816490021555 ()
  • 10816490021558 ()
  • 00816490021551 ()
HDOA-3124

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel DOA Test Dipcard
Healgen Scientific Limited Liability Company
HDOA-6104
In Commercial Distribution

  • 20816490021531 ()
  • 10816490021534 ()
  • 00816490021537 ()
HDOA-6104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel DOA Test Dipcard
Healgen Scientific Limited Liability Company
HDOA-5104
In Commercial Distribution

  • 20816490021524 ()
  • 10816490021527 ()
  • 00816490021520 ()
HDOA-5104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel DOA Test Dipcard
Healgen Scientific Limited Liability Company
HDOA-1104
In Commercial Distribution

  • 20816490021517 ()
  • 10816490021510 ()
  • 00816490021513 ()
HDOA-1104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel DOA Test Dipcard
Healgen Scientific Limited Liability Company
HDOA-3104
In Commercial Distribution

  • 20816490020602 ()
  • 10816490020605 ()
  • 00816490020608 ()
HDOA-3104

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

  • 20816490020589 ()
  • 10816490020582 ()
  • 00816490020585 ()
HDOA-564

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 Panel DOA Test Dipcard
Healgen Scientific Limited Liability Company
HDOA-264
In Commercial Distribution

  • 20816490020558 ()
  • 10816490020551 ()
  • 00816490020554 ()
HDOA-264

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 Panel DOA Test Dipcard
Healgen Scientific Limited Liability Company
HDOA-164
In Commercial Distribution

  • 20816490020527 ()
  • 10816490020520 ()
  • 00816490020523 ()
HDOA-164

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel DOA Test Dipcard
Healgen Scientific Limited Liability Company
HDOA-655
In Commercial Distribution

  • 20816490020503 ()
  • 10816490020506 ()
  • 00816490020509 ()
HDOA-655

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

  • 20816490020480 ()
  • 10816490020483 ()
  • 00816490020486 ()
HDOA-654

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel DOA Test Dipcard
Healgen Scientific Limited Liability Company
HDOA-554
In Commercial Distribution

  • 20816490020473 ()
  • 10816490020476 ()
  • 00816490020479 ()
HDOA-554

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel DOA Test Dipcard
Healgen Scientific Limited Liability Company
HDOA-354
In Commercial Distribution

  • 20816490020466 ()
  • 10816490020469 ()
  • 00816490020462 ()
HDOA-354

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel DOA Test Dipcard
Healgen Scientific Limited Liability Company
HDOA-255
In Commercial Distribution

  • 20816490020459 ()
  • 10816490020452 ()
  • 00816490020455 ()
HDOA-255

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel DOA Test Dipcard
Healgen Scientific Limited Liability Company
HDOA-254K
In Commercial Distribution

  • 20816490020442 ()
  • 10816490020445 ()
  • 00816490020448 ()
HDOA-254K

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel DOA Test Dipcard
Healgen Scientific Limited Liability Company
HDOA-154
In Commercial Distribution

  • 20816490020404 ()
  • 10816490020407 ()
  • 00816490020400 ()
HDOA-154

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
3 Panel DOA Test Dipcard
Healgen Scientific Limited Liability Company
HDOA-234
In Commercial Distribution

  • 20816490020381 ()
  • 10816490020384 ()
  • 00816490020387 ()
HDOA-234

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
3 Panel DOA Test Dipcard
Healgen Scientific Limited Liability Company
HDOA-134
In Commercial Distribution

  • 20816490020374 ()
  • 10816490020377 ()
  • 00816490020370 ()
HDOA-134

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
2 Panel DOA Test Dipcard
Healgen Scientific Limited Liability Company
HDOA-424
In Commercial Distribution

  • 20816490020367 ()
  • 10816490020360 ()
  • 00816490020363 ()
HDOA-424

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Single Panel DOA Test Strip
Healgen Scientific Limited Liability Company
HDCO-101
In Commercial Distribution

  • 20816490020350 ()
  • 10816490020353 ()
  • 00816490020356 ()
HDCO-101

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Single Panel DOA Test Strip
Healgen Scientific Limited Liability Company
HDOP-101
In Commercial Distribution

  • 20816490020343 ()
  • 10816490020346 ()
  • 00816490020349 ()
HDOP-101

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
2 Panel DOA Test Dipcard
Healgen Scientific Limited Liability Company
HDOA-124
In Commercial Distribution

  • 20816490020268 ()
  • 10816490020261 ()
  • 00816490020264 ()
HDOA-124

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