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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No Description
Bioteke Corporation (Wuxi) Co., Ltd.
ST9001-2
In Commercial Distribution

  • 06974541564526 ()
  • 86974541564522 ()


  • General specimen collection kit IVD, clinical
No Description
Bioteke Corporation (Wuxi) Co., Ltd.
ST9001-2
In Commercial Distribution

  • 06974541564373 ()
  • 86974541564379 ()


  • General specimen collection kit IVD, clinical
No Description
Bioteke Corporation (Wuxi) Co., Ltd.
ST9001-2
In Commercial Distribution

  • 86974541564065 ()
  • 06974541564069 ()


  • General specimen collection kit IVD, clinical
3 mL of Transport Medium in screw-cap tube, with minitip flocking swab. 50 pcs per box
Shenzhen Dakewe Bio-engineering Co., Ltd
VN
In Commercial Distribution

  • 06973471967629 ()
  • 16973471967626 ()


  • General specimen collection kit IVD, clinical
3 mL of Transport Medium in screw-cap tube. 100 tests per package
Shenzhen Dakewe Bio-engineering Co., Ltd
VM
In Commercial Distribution

  • 06973471961092 ()
6991014

  • General specimen container IVD, additive/medium
2 mL of Transport Medium in screw-cap tube. 100 tests per package
Shenzhen Dakewe Bio-engineering Co., Ltd
VM
In Commercial Distribution

  • 06973471961085 ()
6991024

  • General specimen container IVD, additive/medium
1 mL of Transport Medium in screw-cap tube. 100 tests per package
Shenzhen Dakewe Bio-engineering Co., Ltd
VM
In Commercial Distribution

  • 06973471961061 ()
6991034

  • General specimen container IVD, additive/medium
1 mL of Transport Medium in screw-cap tube, with minitip flocking swab and regular flocking swab. 50 tests per package
Shenzhen Dakewe Bio-engineering Co., Ltd
VNO
In Commercial Distribution

  • 16973471961020 ()
  • 06973471961023 ()
6991191

  • General specimen collection kit IVD, clinical
1 mL of Transport Medium in screw-cap tube, with regular flocking swab. 50 tests per package
Shenzhen Dakewe Bio-engineering Co., Ltd
VO
In Commercial Distribution

  • 16973471960948 ()
  • 06973471960941 ()
6991121

  • General specimen collection kit IVD, clinical
1.5 mL of Transport Medium in screw-cap tube. 100 tests per package
Shenzhen Dakewe Bio-engineering Co., Ltd
VM
In Commercial Distribution

  • 06973471961078 ()
6991074

  • General specimen container IVD, additive/medium
3 mL of Transport Medium in screw-cap tube, with minitip flocking swab and regular flocking swab. 50 tests per package
Shenzhen Dakewe Bio-engineering Co., Ltd
VNO
In Commercial Distribution

  • 16973471961037 ()
  • 06973471961030 ()
6991391

  • General specimen collection kit IVD, clinical
3 mL of Transport Medium in screw-cap tube, with regular flocking swab. 50 tests per package
Shenzhen Dakewe Bio-engineering Co., Ltd
VO
In Commercial Distribution

  • 06973471960958 ()
  • 16973471960955 ()
6991321

  • General specimen collection kit IVD, clinical
3 mL of Transport Medium in screw-cap tube, with minitip flocking swab. 50 tests per package
Shenzhen Dakewe Bio-engineering Co., Ltd
VN
In Commercial Distribution

  • 16973471960931 ()
  • 06973471960934 ()
6991311

  • General specimen collection kit IVD, clinical
1 mL of Transport Medium in screw-cap tube, with minitip flocking swab. 50 tests per package
Shenzhen Dakewe Bio-engineering Co., Ltd
VN
In Commercial Distribution

  • 06973471960927 ()
  • 16973471960924 ()
6991111

  • General specimen collection kit IVD, clinical
Auris Enrichment Broth, Fill 2mL (Sabouraud Salt Dulcitol Broth with Chloramphenicol & Gentamicin) For the selective enrichment of Candida auris from patient and environmental samples
HARDY DIAGNOSTICS
R12
In Commercial Distribution

  • 00816576026876 ()
  • 00816576026883 ()
R12

  • Differential/selective broth culture medium IVD
SIM (Sulfide, Indole, Motility) Medium, 6ml, 16x125mm tube, order by the package of 10 (Sulfide-Indole-Motility) For the identification of gram negative bacilli based on sulfide production, indole formation, and motility.
HARDY DIAGNOSTICS
7025
Not in Commercial Distribution

  • 00816576026692 ()
  • 00816576026708 ()
7025

  • Differential/selective broth culture medium IVD
TransPRO Viral Transport Medium System, single 16x100mm polypropylene tube, 3ml fill with individually wrapped, sterile, mini-tip, flocked swab with 80mm breakpoint. Hardy Diagnostics’ Viral Transport Medium (VTM) is intended for the collection and transport of clinical specimens for the preservation of viral agents including, Influenza A, Influenza B, Adenovirus, and Echovirus from the collection site to the testing laboratory.
HARDY DIAGNOSTICS
TPV50
In Commercial Distribution

  • 00816576025800 ()
  • 00816576026067 ()
TPV50

  • Microbiological transport medium IVD
ACT II
REMEL, INC.
R124102
In Commercial Distribution

  • 00842558116433 ()


  • General specimen collection kit IVD, clinical
ACT II Dual
REMEL, INC.
R124101
In Commercial Distribution

  • 00842558116426 ()


  • General specimen collection kit IVD, clinical
ACT I
REMEL, INC.
R124100
In Commercial Distribution

  • 00842558116419 ()


  • General specimen collection kit IVD, clinical
M4RT (3ml) no BEADS Nasal Swab Kit w/bag
Remel Inc.
R12952
In Commercial Distribution

  • 00842558112602 ()
R12952

  • Microbiological transport medium IVD
M4RT(3ml) 2NPG Swab KIT
Remel Inc.
R12901
In Commercial Distribution

  • 00842558110202 ()
R12901

  • Microbiological transport medium IVD
M4RT(3ml) Dual Swab KIT
Remel Inc.
R12900
In Commercial Distribution

  • 00842558109718 ()
R12900

  • Microbiological transport medium IVD
M4RT(3ml) w/o beads PK/72
REMEL, INC.
R12700
In Commercial Distribution

  • 00842558108919 ()
R12700

  • Microbiological transport medium IVD
M4RT Tube PK/72
REMEL, INC.
R12587
In Commercial Distribution

  • 00842558107004 ()
R12587

  • Microbiological transport medium IVD
M4RT KIT w/ FLOCKED SWAB PK/100
REMEL, INC.
R12588
In Commercial Distribution

  • 00842558106939 ()
R12588

  • Microbiological transport medium IVD
Saliva substitue - protective oral spray
K Pharmaceuticals, LLC
196852643219
In Commercial Distribution

  • 10196852643216 ()
  • 00196852643219 ()


  • Medication spray bottle
No Description
Sarstedt Aktiengesellschaft & Co.KG
11.2253.001
In Commercial Distribution

  • 04038917245135 ()
  • 04038917245128 ()
11.2253.001

  • Evacuated urine specimen container IVD, preservative
No Description
Sarstedt Aktiengesellschaft & Co.KG
10.260.021
In Commercial Distribution

  • 04038917993678 ()
  • 04038917993685 ()


  • Non-evacuated urine specimen container IVD, preservative
No Description
Sarstedt Aktiengesellschaft & Co.KG
10.260.001
In Commercial Distribution

  • 04038917993593 ()
  • 04038917993616 ()


  • Non-evacuated urine specimen container IVD, preservative
No Description
Sarstedt Aktiengesellschaft & Co.KG
10.256.021
In Commercial Distribution

  • 04038917983136 ()
  • 04038917983143 ()


  • Non-evacuated urine specimen container IVD, preservative
No Description
Sarstedt Aktiengesellschaft & Co.KG
10.256.001
In Commercial Distribution

  • 04038917982818 ()
  • 04038917982825 ()


  • Non-evacuated urine specimen container IVD, preservative
No Description
Sarstedt Aktiengesellschaft & Co.KG
10.253
In Commercial Distribution

  • 04038917163354 ()
  • 04038917279918 ()
10.253

  • Non-evacuated urine specimen container IVD, preservative
No Description
Sarstedt Aktiengesellschaft & Co.KG
11.2453.001
In Commercial Distribution

  • 04038917263436 ()
  • 04038917263429 ()
11.2453.001

  • Evacuated urine specimen container IVD, preservative
No Description
Sarstedt Aktiengesellschaft & Co.KG
10.253.020
In Commercial Distribution

  • 04038917183147 ()
  • 04038917104548 ()
10.253.020

  • Non-evacuated urine specimen container IVD, preservative
The Para-Pak C&S (Culture and Sensitivity) and Para-Pak Enteric Plus provide a standardized procedure for the routine collection, transportation, preservation, and culture of stool specimens for bacterial enteric pathogens. It is designed for easy collection of specimens by individuals not trained in microbiological techniques and affords an excellent means of minimizing the adverse effects of delay in specimen transportation.
MERIDIAN BIOSCIENCE, INC.
900612
In Commercial Distribution

  • 00840733102714 ()
900612

  • Faecal specimen container IVD, transport buffer/medium
The Para-Pak C&S (Culture and Sensitivity) and Para-Pak Enteric Plus provide a standardized procedure for the routine collection, transportation, preservation, and culture of stool specimens for bacterial enteric pathogens. It is designed for easy collection of specimens by individuals not trained in microbiological techniques and affords an excellent means of minimizing the adverse effects of delay in specimen transportation.
MERIDIAN BIOSCIENCE, INC.
900612
In Commercial Distribution

  • 00840733102011 ()
900612

  • Faecal specimen container IVD, transport buffer/medium
Meridian Viral Transport is a system which contains all materials necessary to collect and transport clinical specimens for viral isolation.
MERIDIAN BIOSCIENCE, INC.
505021
In Commercial Distribution

  • 00840733101410 ()
505021

  • General specimen collection kit IVD, clinical
The Para-Pak C&S (Culture and Sensitivity) and Para-Pak Enteric Plus provide a standardized procedure for the routine collection, transportation, preservation, and culture of stool specimens for bacterial enteric pathogens. It is designed for easy collection of specimens by individuals not trained in microbiological techniques and affords an excellent means of minimizing the adverse effects of delay in specimen transportation.
MERIDIAN BIOSCIENCE, INC.
9006-01
In Commercial Distribution

  • 00840733103339 ()
900612

  • Faecal specimen container IVD, transport buffer/medium
Collection and Transport Swab Microorganism Collection and Transport System
CARDINAL HEALTH 200, LLC
C8552-11W
In Commercial Distribution

  • 20885380163521 ()
  • 10885380163524 ()
  • 50885380163522 ()
C8552-11W

  • General specimen collection kit IVD, clinical
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