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

Show Filters

Nasal Sample Collect Kit for Viruses
CEPHEID
SWAB/F-100
In Commercial Distribution

  • 07332940006457 ()
SWAB/F-100

  • General specimen collection kit IVD, clinical
Xpert Nasopharyngeal Sample Collection Kit; 100 pack
CEPHEID
SWAB/B-100
In Commercial Distribution

  • 07332940002565 ()
SWAB/B-100

  • General specimen collection kit IVD, clinical
UTM VIRO+2A/PL DAC.BREAK 500 Double plastic applicators polyester tipped
COPAN ITALIA SPA
302CB.MDL
In Commercial Distribution

  • 18053326002851 ()
  • 58053326002859 ()
302CB.MDL

  • General specimen collection kit
Reusable electrode gel pads.
BEAR DOWN CONSULTING
PEHTNPDS5
In Commercial Distribution

  • B311PEHTNPDS51 ()
  • B311PEHTNPDS50 ()
  • B311PEHTNPDS52 ()


  • Transcutaneous electrical stimulation electrode, single-use
Reusable electrode gel pads.
BEAR DOWN CONSULTING
PEHTNPDS2
In Commercial Distribution

  • B311PEHTNPDS21 ()
  • B311PEHTNPDS20 ()
  • B311PEHTNPDS22 ()


  • Transcutaneous electrical stimulation electrode, single-use
Wired TENS+EMS+HEAT Replacement Gel Pads
BEAR DOWN CONSULTING
PETNEMPD5
In Commercial Distribution

  • B311PETNEMPD51 ()
  • B311PETNEMPD5 ()
  • B311PETNEMPD52 ()


  • Transcutaneous electrical stimulation electrode, single-use
Wired TENS+EMS+HEAT Replacement Gel Pads 2 sets
BEAR DOWN CONSULTING
PETNEMPD2
In Commercial Distribution

  • B311PETNEMPD21 ()
  • B311PETNEMPD2 ()
  • B311PETNEMPD22 ()


  • Transcutaneous electrical stimulation electrode, single-use
Tryptic Soy Broth (TSB) with 6.5% Sodium Chloride, 15x45mm Tube without tube label, 1.5ml fill, order by the package of 100 For the differentiation of Enterococci from Group D Streptococci.
HARDY DIAGNOSTICS
D07
Not in Commercial Distribution

  • 00816576020003 ()
  • 00816576029075 ()
D07

  • Differential/selective broth culture medium IVD
The VTM-C19 Transit Tube contains a viral transport medium (VTM) intended to be inoculated with nasopharyngeal (NP) or oropharyngeal (OP) synthetic fiber swab specimens (Not provided), transported appropriately to the lab and analyzed with validated qRT-PCR assays for the detection of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that causes COVID-19 disease in humans. Manufacturers Note: Under enforcement discretion, we are currently exempt of having 510(k) during emergency and threat of Covid.
BIO-MED DIAGNOSTICS, INC.
1602
In Commercial Distribution

  • B08816026 ()
  • B08816020 ()
  • B08816021 ()
11-602-001

  • Viral transport medium IVD
Self-contained media system for the recovery and detection of T. vaginalis from female vaginal samples or male urethra/urine samples.
BIO-MED DIAGNOSTICS, INC.
1031
In Commercial Distribution

  • B08810310 ()
  • B08810317 ()
  • B08810313 ()
21-031-001

  • Differential/selective broth culture medium IVD
For the detail information, please refer to the IFU.
Hangzhou Bioer Technology Co., Ltd.
BSC85M1
In Commercial Distribution

  • 06973843228389 ()


  • General specimen container IVD, additive/medium
For the detail information, please refer to the IFU.
Hangzhou Bioer Technology Co., Ltd.
BSC85S1
In Commercial Distribution

  • 06973843228372 ()


  • General specimen container IVD, additive/medium
For the detail information, please refer to the IFU.
Hangzhou Bioer Technology Co., Ltd.
BSC85X1-C2
In Commercial Distribution

  • 06973843228365 ()


  • General specimen container IVD, additive/medium
For the detail information, please refer to the IFU.
Hangzhou Bioer Technology Co., Ltd.
BSC85X1-C
In Commercial Distribution

  • 06973843228341 ()


  • General specimen container IVD, additive/medium
For the detail information, please refer to the IFU.
Hangzhou Bioer Technology Co., Ltd.
BSC85X1-B1
In Commercial Distribution

  • 06973843228327 ()


  • General specimen container IVD, additive/medium
For the detail information, please refer to the IFU.
Hangzhou Bioer Technology Co., Ltd.
BSC85X1-A2
In Commercial Distribution

  • 06973843228303 ()


  • General specimen container IVD, additive/medium
For the detail information, please refer to the IFU.
Hangzhou Bioer Technology Co., Ltd.
BSC85X1-A1
In Commercial Distribution

  • 06973843228297 ()


  • General specimen container IVD, additive/medium
For the detail information, please refer to the IFU.
Hangzhou Bioer Technology Co., Ltd.
BSC85N1-2
In Commercial Distribution

  • 06973843228273 ()


  • General specimen container IVD, additive/medium
For the detail information, please refer to the IFU.
Hangzhou Bioer Technology Co., Ltd.
BSC85N1
In Commercial Distribution

  • 06973843228259 ()


  • General specimen container IVD, additive/medium
For the detail information, please refer to the IFU.
Hangzhou Bioer Technology Co., Ltd.
BSC85L1
In Commercial Distribution

  • 06973843228396 ()


  • General specimen container IVD, additive/medium
For the detail information, please refer to the IFU.
Hangzhou Bioer Technology Co., Ltd.
BSC85X1-C1
In Commercial Distribution

  • 06973843228358 ()


  • General specimen container IVD, additive/medium
For the detail information, please refer to the IFU.
Hangzhou Bioer Technology Co., Ltd.
BSC85X1-B2
In Commercial Distribution

  • 06973843228334 ()


  • General specimen container IVD, additive/medium
For the detail information, please refer to the IFU.
Hangzhou Bioer Technology Co., Ltd.
BSC85X1-B
In Commercial Distribution

  • 06973843228310 ()


  • General specimen container IVD, additive/medium
For the detail information, please refer to the IFU.
Hangzhou Bioer Technology Co., Ltd.
BSC85X1-A
In Commercial Distribution

  • 06973843228280 ()


  • General specimen container IVD, additive/medium
For the detail information, please refer to the IFU.
Hangzhou Bioer Technology Co., Ltd.
BSC85N1-1
In Commercial Distribution

  • 06973843228266 ()


  • General specimen container IVD, additive/medium
Urine CCM / Z Urine No Additive Set with Transfer Device <(>&<)> Towelette consisting of: Item No. 454486 VACUETTE® TUBE 4 ml Urine CCM, 13x75, Round Base Item No. 455028 VACUETTE® TUBE 9 ml Z Urine No Additive, 16x100, Conical Base Item No. 450251 Urine Transfer Device, short Castile Soap Towelette single-packed
Greiner Bio-One GmbH
453044
In Commercial Distribution

  • 29120049209105 ()
  • 19120049209108 ()


  • Evacuated urine specimen container IVD, no additive
  • Evacuated blood collection tube IVD, K3EDTA
  • Urine transfer IVD, sterile
Urine CCM Set with Beaker <(>&<)> Towelette consisting of: Item No. 454486 VACUETTE® TUBE 4 ml Urine CCM, 13x75, Round Base Item No. 724310 Urine Beaker with integrated Transfer Device 100 ml Castile Soap Towelette single-packed
Greiner Bio-One GmbH
453043
In Commercial Distribution

  • 29120049209099 ()
  • 19120049209092 ()


  • General specimen container IVD, no additive, sterile
  • Evacuated blood collection tube IVD, K3EDTA
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
< 1 ... 56 57 58 59 60 ... 200 >