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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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N/A - 00819398021173

Thioglycollate with H and K (Hemin and Vitamin K), filtered (to remove dead bacteria), 10ml fill, 16x125mm tube, 20 tubes/pack For the cultivation of fastidious anaerobic bacteria. Filtered to remove all dead bacteria and debris.
HARDY DIAGNOSTICS
K24
In Commercial Distribution

  • 00819398021166 ()
  • 00819398021173 ()
K24

  • Basic/simple nutrient broth culture medium IVD

N/A - 00819398021159

MR-VP, 2mL, 15x100mm tube, 20 tubes/pack (Methyl Red and Voges-Proskauer) For the identification of gram negative bacilli.
HARDY DIAGNOSTICS
K237
In Commercial Distribution

  • 00819398021142 ()
  • 00819398021159 ()
K237

  • Differential/selective broth culture medium IVD

N/A - 00819398021111

Thioglycollate with Supplements, (Hemin, Vitamin K, and Calcium Carbonate Chip), 16x125mm tube, 20 tubes/box (Thioglycollate without indicator, with hemin, vitamin K, and calcium carbonate chip a a buffer) For the cultivation of bacteria including fastidious anaerobes. Filtered to remove dead bacteria and debris.
HARDY DIAGNOSTICS
K23
In Commercial Distribution

  • 00819398021104 ()
  • 00819398021111 ()
K23

  • Basic/simple nutrient broth culture medium IVD

N/A - 00819398021036

Thioglycollate with Indicator, 16x125mm Tube, 10ml. Hardy Diagnostics Thioglycollate Media is recommended for the cultivation of aerobic, microaerophilic, and anaerobic microorganisms.
HARDY DIAGNOSTICS
K21
In Commercial Distribution

  • 00819398021029 ()
  • 00819398021036 ()
K21

  • Basic/simple nutrient broth culture medium IVD

N/A - 00819398020893

Pyrazinamidase Agar, 16x125mm Tube, 5ml Deep. Hardy Diagnostics Pyrazinamidase Agar is used to differentiate Mycobacterium species on the basis of pyrazinamidase activity.
HARDY DIAGNOSTICS
K158
Not in Commercial Distribution

  • 00819398020886 ()
  • 00819398020893 ()
K158

  • Differential/selective agar culture medium IVD

N/A - 00819398020879

MR-VP Broth, 5mL, 15x103mm tube, 20 tubes/box (Methyl Red and Voges-Proskauer) For the identification of gram negative bacilli
HARDY DIAGNOSTICS
K156
Not in Commercial Distribution

  • 00819398020862 ()
  • 00819398020879 ()
K156

  • Differential/selective broth culture medium IVD

N/A - 00819398020855

Indole Nitrate Medium with Durham Tube, 15x103mm Tube, 6ml. Hardy Diagnostics Indole Nitrate Medium is recommended for the detection of indole production and nitrate reduction by microorganisms with a wide range of oxygen tolerances including aerobes, microaerophiles, facultative anaerobes, and obligate anaerobes.
HARDY DIAGNOSTICS
K147
Not in Commercial Distribution

  • 00819398020848 ()
  • 00819398020855 ()
K147

  • Differential/selective broth culture medium IVD

N/A - 00819398020831

Nutrient Broth, 5mL, 15x103mm tube, 20 tubes/box For the cultivation of non-fastidious microorganisms
HARDY DIAGNOSTICS
K142
Not in Commercial Distribution

  • 00819398020824 ()
  • 00819398020831 ()
K142

  • Basic/simple nutrient broth culture medium IVD

N/A - 00819398020817

Tryptic Soy Broth (TSB) with 0.075% Phytagel™, 16x125mm Tube, 10ml. Hardy Diagnostics Tryptic Soy Broth (TSB) with 0.075% Phytagel™ is a growth medium recommended for the growth of aerotolerant and anaerobic microorganisms.
HARDY DIAGNOSTICS
K132
Not in Commercial Distribution

  • 00819398020800 ()
  • 00819398020817 ()
K132

  • Differential/selective broth culture medium IVD

N/A - 00819398020794

TSB, 2mL, 15x105mm tube, 20 tubes/box (Tryptic Soy Broth) For sterility testing and cultivation of microorganisms. Also known as Soybean-Casein Digest Broth, USP.
HARDY DIAGNOSTICS
K131
In Commercial Distribution

  • 00819398020787 ()
  • 00819398020794 ()
K131

  • Basic/simple nutrient broth culture medium IVD

N/A - 00819398020770

Campy Thioglycollate, 16x100mm Tube, 6ml. Hardy Diagnostics Campy Thioglycollate is a selective medium used to aid in the isolation of Campylobacter species from stool specimens.
HARDY DIAGNOSTICS
K128
In Commercial Distribution

  • 00819398020763 ()
  • 00819398020770 ()
K128

  • Differential/selective broth culture medium IVD

N/A - 00819398020718

Todd Hewitt Broth, 15x103mm Tube, 1ml. Hardy Diagnostics Todd Hewitt Broth is recommended for the production of antigenic streptococcal hemolysin and the cultivation of streptococci prior to serological grouping. It is also recommended for the cultivation of beta-hemolytic streptococci, pneumococci, and other fastidious organisms.
HARDY DIAGNOSTICS
K112
In Commercial Distribution

  • 00819398020701 ()
  • 00819398020718 ()
K112

  • Basic/simple nutrient broth culture medium IVD

N/A - 00819398020695

BHI Broth, 15x103mm Tube, 1ml. Hardy Diagnostics Brain Heart Infusion (BHI) Broth is a general purpose nutrient medium recommended for the cultivation and isolation of a variety of fastidious and nonfastidious microorganisms, including bacteria, yeast, and mold.
HARDY DIAGNOSTICS
K110
In Commercial Distribution

  • 00819398020688 ()
  • 00819398020695 ()
K110

  • Basic/simple nutrient broth culture medium IVD

HardyCHROM™ - 00819398020541

HardyCHROM™ Campy Agar, 15x100mm plate, 10/pk. Screening medium for the selective isolation and chromogenic differentiation of Campylobacter jejuni, C.lari, C.coli, and C.fetus from direct stool cultures, or from food or poultry samples. Some ingredients are very light sensitive. Store and incubate media in the dark.
HARDY DIAGNOSTICS
G339
In Commercial Distribution

  • 00819398020541 ()
  • 00819398020534 ()
G339

  • Differential/selective agar culture medium IVD

N/A - 00819398020497

Wallenstein, 20x125mm Tube, 10ml Slant. Hardy Diagnostics Wallenstein Media are recommended for use in the cultivation and isolation of mycobacteria other than tuberculosis. It is particularly useful in the recovery of Mycobacteria avium complex.
HARDY DIAGNOSTICS
C61
In Commercial Distribution

  • 00819398020480 ()
  • 00819398020497 ()
C61

  • Differential/selective broth culture medium IVD

N/A - 00819398020473

Trichophyton Agar #7, 20x125mm Tube, 10.5ml Slant. Hardy Diagnostics Trichophyton Media numbers 1-7 are used as an aid in the identification of various Trichophyton species.
HARDY DIAGNOSTICS
C57
Not in Commercial Distribution

  • 00819398020466 ()
  • 00819398020473 ()
C57

  • Differential/selective agar culture medium IVD

N/A - 00819398020459

Trichophyton Agar #6, 20x125mm Tube, 10.5ml Slant. Hardy Diagnostics Trichophyton Media numbers 1-7 are used as an aid in the identification of various Trichophyton species.
HARDY DIAGNOSTICS
C56
Not in Commercial Distribution

  • 00819398020442 ()
  • 00819398020459 ()
C56

  • Differential/selective agar culture medium IVD

N/A - 00819398020435

Trichophyton Agar #5, 20x125mm Tube, 10.5ml Slant. Hardy Diagnostics Trichophyton Media numbers 1-7 are used as an aid in the identification of various Trichophyton species.
HARDY DIAGNOSTICS
C55
Not in Commercial Distribution

  • 00819398020428 ()
  • 00819398020435 ()
C55

  • Differential/selective agar culture medium IVD

N/A - 00819398020411

Trichophyton Agar #4, 20x125mm Tube, 10.5ml Slant. Hardy Diagnostics Trichophyton Media numbers 1-7 are used as an aid in the identification of various Trichophyton species.
HARDY DIAGNOSTICS
C54
In Commercial Distribution

  • 00819398020404 ()
  • 00819398020411 ()
C54

  • Differential/selective agar culture medium IVD

N/A - 00819398020398

Trichophyton Agar #3, 20x125mm Tube, 10.5ml Slant. Hardy Diagnostics Trichophyton Media numbers 1-7 are used as an aid in the identification of various Trichophyton species.
HARDY DIAGNOSTICS
C53
In Commercial Distribution

  • 00819398020381 ()
  • 00819398020398 ()
C53

  • Differential/selective agar culture medium IVD

N/A - 00819398020374

Trichophyton Agar #2, 20x125mm Tube, 10.5ml Slant. Hardy Diagnostics Trichophyton Media numbers 1-7 are used as an aid in the identification of various Trichophyton species.
HARDY DIAGNOSTICS
C52
In Commercial Distribution

  • 00819398020367 ()
  • 00819398020374 ()
C52

  • Differential/selective agar culture medium IVD

N/A - 00819398020350

Trichophyton Agar #1, 20x125mm Tube, 10.5ml Slant. Hardy Diagnostics Trichophyton Media numbers 1-7 are used as an aid in the identification of various Trichophyton species.
HARDY DIAGNOSTICS
C51
In Commercial Distribution

  • 00819398020343 ()
  • 00819398020350 ()
C51

  • Differential/selective agar culture medium IVD

N/A - 00819398020312

Middlebrook 7H11 Select Slant, 20x125 tube, 100 tubes/box (Mitchison formula with CAPT antibiotics) For selective isolation of Mycobacterium spp.
HARDY DIAGNOSTICS
C38BX
In Commercial Distribution

  • 00819398020305 ()
  • 00819398020312 ()
C38BX

  • Differential/selective agar culture medium IVD

N/A - 00819398020251

Middlebrook 7H9 Broth, 16x125mm Tube, 10ml. Hardy Diagnostics Middlebrook 7H9 Broth and Middlebrook 7H9 Broth with Tween® 80 are recommended for use in the cultivation of Mycobacterium spp. The media are also used for preparing dilutions of mycobacteria for antimicrobial testing.
HARDY DIAGNOSTICS
C32
In Commercial Distribution

  • 00819398020244 ()
  • 00819398020251 ()
C32

  • Differential/selective broth culture medium IVD

N/A - 00819398020237

Lowenstein-Jensen with 5% NaCl, 20x125mm Tube, 10ml Slant. Hardy Diagnostics Lowenstein-Jensen with 5% NaCl is used to test Mycobacterium species for salt tolerance.
HARDY DIAGNOSTICS
C29
In Commercial Distribution

  • 00819398020220 ()
  • 00819398020237 ()
C29

  • Differential/selective broth culture medium IVD

N/A - 00819398020213

LJ with Pyruvate, 20x125mm Tube, Slant. Hardy Diagnostics Lowenstein Jensen Media are recommended for use in the cultivation and isolation of Mycobacterium species.
HARDY DIAGNOSTICS
C28
In Commercial Distribution

  • 00819398020206 ()
  • 00819398020213 ()
C28

  • Differential/selective broth culture medium IVD

N/A - 00819398020190

Lowenstein Jensen Medium, 20x125mm Tube, 5ml Deep. Hardy Diagnostics Lowenstein Jensen Deep is recommended for use in the semiquantitative catalase test to aid in differentiation of Mycobacterium species.
HARDY DIAGNOSTICS
C27
In Commercial Distribution

  • 00819398020183 ()
  • 00819398020190 ()
C27

  • Differential/selective broth culture medium IVD

N/A - 00819398020176

LJ, Selective, 20x125mm Tube, Slant. Hardy Diagnostics Lowenstein Jensen Media are recommended for use in the cultivation and isolation of Mycobacterium species.
HARDY DIAGNOSTICS
C25
In Commercial Distribution

  • 00819398020169 ()
  • 00819398020176 ()
C25

  • Differential/selective broth culture medium IVD

N/A - 00819398020152

LJ, Gruft Modification, 20x125mm Tube, Slant. Hardy Diagnostics Lowenstein Jensen Media are recommended for use in the cultivation and isolation of Mycobacterium species.
HARDY DIAGNOSTICS
C23
In Commercial Distribution

  • 00819398020145 ()
  • 00819398020152 ()
C23

  • Differential/selective broth culture medium IVD

N/A - 00819398020138

Lowenstein Jensen, 20x125mm Tube, Slant. Hardy Diagnostics Lowenstein Jensen Media are recommended for use in the cultivation and isolation of Mycobacterium species.
HARDY DIAGNOSTICS
C21
In Commercial Distribution

  • 00819398020121 ()
  • 00819398020138 ()
C21

  • Differential/selective broth culture medium IVD

AnaeroGRO - 00819398020114

Peptone Yeast Extract Glucose Broth, 16x125mm Tube with Hungate Septum Cap, 9ml. Hardy Diagnostics AnaeroGRO™ Peptone Yeast Extract Glucose Broth (PYG) is an enriched, non-selective medium recommended for the cultivation and biochemical identification of obligately anaerobic microorganisms. This medium is also suitable for the growth of anaerobic bacteria to be identified by gas liquid chromatography (GLC) analysis as outlined by the CDC.
HARDY DIAGNOSTICS
AG24H
Not in Commercial Distribution

  • 00819398020107 ()
  • 00819398020114 ()
AG24H

  • Enriched broth culture medium IVD

N/A - 00819398020015

Nitrate Broth, 6mL, 15x103mm tube, 20 tubes/box For the determination of nitrate reduction and gas production of bacteria. Contains a durham tube.
HARDY DIAGNOSTICS
K42
In Commercial Distribution

  • 00819398020008 ()
  • 00819398020015 ()
K42

  • Differential/selective broth culture medium IVD

Microbank (with 2D Barcodes)-Yellow (80 vials) - 10628429002183

Advanced presentation of 80 vials with yellow caps and beads supplied in a plastic freezer box manufactured from durable plastic with “see through” lids, number locator printed screens, and tube collection device.
PRO-LAB, INCORPORATED
PL.170C/Y
In Commercial Distribution

  • 10628429002183 ()
PL.170C/Y

  • Basic/simple nutrient broth culture medium IVD

Microbank (with 2D Barcodes)-Red (80 vials) - 10628429002176

No Description
PRO-LAB, INCORPORATED
PL.170C/R
In Commercial Distribution

  • 10628429002176 ()
PL.170C/R

  • Basic/simple nutrient broth culture medium IVD

Microbank (with 2D Barcodes)-Mixed (80 vials) - 10628429002169

Advanced presentation of 80 vials with 16 vials of each colour supplied in a plastic freezer box manufactured from durable plastic with “see through” lids, number locator printed screens, and tube collection device.
PRO-LAB, INCORPORATED
PL.170C/M
In Commercial Distribution

  • 10628429002169 ()
PL.170C/M

  • Basic/simple nutrient broth culture medium IVD

Microbank (with 2D Barcodes)-Light Blue (80 vials) - 10628429002152

Advanced presentation of 80 vials with light blue caps and beads supplied in a plastic freezer box manufactured from durable plastic with “see through” lids, number locator printed screens, and tube collection device.
PRO-LAB, INCORPORATED
PL.170C/LB
In Commercial Distribution

  • 10628429002152 ()
PL.170C/LB

  • Basic/simple nutrient broth culture medium IVD

Microbank (with 2D Barcodes)-Green (80 vials) - 10628429002145

Advanced presentation of 80 vials with green caps and beads supplied in a plastic freezer box manufactured from durable plastic with “see through” lids, number locator printed screens, and tube collection device.
PRO-LAB, INCORPORATED
PL.170C/G
In Commercial Distribution

  • 10628429002145 ()
PL.170C/G

  • Basic/simple nutrient broth culture medium IVD

Microbank (with 2D Barcodes) -Blue (80 vials) - 10628429002138

Advanced presentation of 80 vials with blue caps and beads supplied in a plastic freezer box manufactured from durable plastic with “see through” lids, number locator printed screens, and tube collection device.
PRO-LAB, INCORPORATED
PL.170C/B
In Commercial Distribution

  • 10628429002138 ()
PL.170C/B

  • Basic/simple nutrient broth culture medium IVD

Microbank Broth Only -Yellow (80 vials) - 10628429000974

Microbank Broth Only -Yellow (80 vials)
PRO-LAB, INCORPORATED
PL.173/Y
In Commercial Distribution

  • 10628429000974 ()
PL.173/Y

  • Basic/simple nutrient broth culture medium IVD

Microbank Broth Only -Red (80 vials) - 10628429000967

Microbank Broth Only -Red (80 vials)
PRO-LAB, INCORPORATED
PL.173/R
In Commercial Distribution

  • 10628429000967 ()
PL.173/R

  • Basic/simple nutrient broth culture medium IVD

Microbank Broth Only-Mixed (80 vials) - 10628429000950

Microbank Broth Only-Mixed (80 vials)
PRO-LAB, INCORPORATED
PL.173/M
In Commercial Distribution

  • 10628429000950 ()
PL.173/M

  • Basic/simple nutrient broth culture medium IVD

Microbank Broth Only -Light Blue (80 vials) - 10628429000943

Microbank Broth Only -Light Blue (80 vials)
PRO-LAB, INCORPORATED
PL.173/LB
In Commercial Distribution

  • 10628429000943 ()
PL.173/LB

  • Basic/simple nutrient broth culture medium IVD

Microbank Broth Only -Green (80 vials) - 10628429000936

Microbank Broth Only -Green (80 vials)
PRO-LAB, INCORPORATED
PL.173/G
In Commercial Distribution

  • 10628429000936 ()
PL.173/G

  • Basic/simple nutrient broth culture medium IVD

Microbank Broth Only -Blue (80 vials) - 10628429000929

Microbank Broth Only
PRO-LAB, INCORPORATED
PL.173/B
In Commercial Distribution

  • 10628429000929 ()
PL.173/B

  • Basic/simple nutrient broth culture medium IVD

Microbank Dry - Yellow (80 vials) - 10628429000912

Supplied in the same format as traditional Microbank™ without the specially formulated cryopreservation solution.
PRO-LAB, INCORPORATED
PL.172/Y
In Commercial Distribution

  • 10628429000912 ()
PL.172/Y

  • Basic/simple nutrient broth culture medium IVD

Microbank Dry - Red (80 vials) - 10628429000905

Supplied in the same format as traditional Microbank™ without the specially formulated cryopreservation solution.
PRO-LAB, INCORPORATED
PL.172/R
In Commercial Distribution

  • 10628429000905 ()
PL.172/R

  • Basic/simple nutrient broth culture medium IVD

Microbank Dry - Mixed (80 vials) - 10628429000899

Supplied in the same format as traditional Microbank™ without the specially formulated cryopreservation solution.
PRO-LAB, INCORPORATED
PL.172/M
In Commercial Distribution

  • 10628429000899 ()
PL.172/M

  • Basic/simple nutrient broth culture medium IVD

Microbank Dry- Light Blue (80 vials) - 10628429000882

Supplied in the same format as traditional Microbank™ without the specially formulated cryopreservation solution.
PRO-LAB, INCORPORATED
PL.172/LB
In Commercial Distribution

  • 10628429000882 ()
PL.172/LB

  • Basic/simple nutrient broth culture medium IVD

Microbank Dry - Green (80 vials) - 10628429000875

Supplied in the same format as traditional Microbank™ without the specially formulated cryopreservation solution.
PRO-LAB, INCORPORATED
PL.172/G
In Commercial Distribution

  • 10628429000875 ()
PL.172/G

  • Basic/simple nutrient broth culture medium IVD

Microbank Dry - Blue (80 vials) - 10628429000868

Supplied in the same format as traditional Microbank™ without the specially formulated cryopreservation solution.
PRO-LAB, INCORPORATED
PL.172/B
In Commercial Distribution

  • 10628429000868 ()
PL.172/B

  • Basic/simple nutrient broth culture medium IVD
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