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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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BioSci™ - 06973471960927

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

N/A - 00816576026883

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

N/A - 00816576026708

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 - 00816576026067

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 Dual Transport PK/10 - 00842558116433

ACT II
REMEL, INC.
R124102
In Commercial Distribution

  • 00842558116433 ()


  • General specimen collection kit IVD, clinical

ACT II Transport PK/10 - 00842558116426

ACT II Dual
REMEL, INC.
R124101
In Commercial Distribution

  • 00842558116426 ()


  • General specimen collection kit IVD, clinical

ACT I Transport PK/10 - 00842558116419

ACT I
REMEL, INC.
R124100
In Commercial Distribution

  • 00842558116419 ()


  • General specimen collection kit IVD, clinical

MicroTest M4RT - 00842558112602

M4RT (3ml) no BEADS Nasal Swab Kit w/bag
Remel Inc.
R12952
In Commercial Distribution

  • 00842558112602 ()
R12952

  • Microbiological transport medium IVD

MicroTest M4RT - 00842558110202

M4RT(3ml) 2NPG Swab KIT
Remel Inc.
R12901
In Commercial Distribution

  • 00842558110202 ()
R12901

  • Microbiological transport medium IVD

MicroTest M4RT - 00842558109718

M4RT(3ml) Dual Swab KIT
Remel Inc.
R12900
In Commercial Distribution

  • 00842558109718 ()
R12900

  • Microbiological transport medium IVD
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