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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 - 00819398024563

Middlebrook ADC Supplement, 20ml, 1 ounce bottle, order by the package of 10 For use as a supplement for Middlebrook media.
HARDY DIAGNOSTICS
X95
In Commercial Distribution

  • 00819398024556 ()
  • 00819398024563 ()
X95

  • Culture medium nutrient supplement IVD

HardyFlask™ - 00819398024266

Middlebrook 7H11 Selective, 12ml, 50ml plastic HardyFlask™, order by the package of 20 Middlebrook 7H11 Agar is recommended for use in the isolation and cultivation of Mycobacterium species.
HARDY DIAGNOSTICS
X28
In Commercial Distribution

  • 00819398024259 ()
  • 00819398024266 ()
X28

  • Enriched agar culture medium IVD

HardyFlask™ - 00819398024242

Middlebrook 7H10 Agar, 12ml fill, 50ml plastic HardyFlask™, order by the package of 20 Middlebrook 7H10 Agar is recommended for use in qualitative procedures for the isolation and cultivation of Mycobacterium species.
HARDY DIAGNOSTICS
X26
In Commercial Distribution

  • 00819398024235 ()
  • 00819398024242 ()
X26

  • Enriched agar culture medium IVD

HardyFlask™ - 00819398024228

Middlebrook 7H11 Agar, 12ml, 50ml plastic HardyFlask™, order by the package of 20 Middlebrook 7H11 Agar is recommended for use in the isolation and cultivation of Mycobacterium species.
HARDY DIAGNOSTICS
X25
In Commercial Distribution

  • 00819398024211 ()
  • 00819398024228 ()
X25

  • Enriched agar culture medium IVD

N/A - 00819398023535

Middlebrook 7H11 Slant, 3ml, 13x100mm tube slant, order by the package of 20 For the isolation and cultivation of Mycobacterium spp.
HARDY DIAGNOSTICS
R49
Not in Commercial Distribution

  • 00819398023528 ()
  • 00819398023535 ()
R49

  • Enriched agar culture medium IVD

N/A - 00819398022293

Chocolate Agar Slant, 5.5ml, 16x100mm tube, order by the package of 20 (GC Agar Base with 1% hemoglobin and enrichments) For the cultivation of fastidious bacteria.
HARDY DIAGNOSTICS
L37
In Commercial Distribution

  • 00819398022286 ()
  • 00819398022293 ()
L37

  • Enriched agar culture medium IVD

N/A - 00819398022194

Loeffler's Slant, 5.5ml, 16x100mm tube, order by the package of 20 For the cultivation of Corynebacterium diphtheriae from clinical specimens.
HARDY DIAGNOSTICS
L28
In Commercial Distribution

  • 00819398022187 ()
  • 00819398022194 ()
L28

  • Enriched agar culture medium IVD

N/A - 00819398021715

Brain Heart Infusion Broth with Hemin and Vitamin K (BHI Broth w/H&K), 16x125mm tube, 10ml fill, order by the package of 20 For the cultivation of fastidious bacteria.
HARDY DIAGNOSTICS
K75
In Commercial Distribution

  • 00819398021708 ()
  • 00819398021715 ()
K75

  • Enriched broth culture medium IVD

N/A - 00819398021692

Columbia Broth, 8ml fill, 16x125mm glass tube, order by the package of 20 For use in the cultivation of fastidious microorganisms
HARDY DIAGNOSTICS
K74
Not in Commercial Distribution

  • 00819398021685 ()
  • 00819398021692 ()
K74

  • Enriched broth culture medium IVD

AnaeroGRO - 00819398021470

Chopped Meat Glucose Broth, 16x125mm Tube with Hungate Septum Cap, 9ml. Hardy Diagnostics AnaeroGRO™ Chopped Meat Media is recommended for the cultivation of microaerophilic, facultative and obligate anaerobic microorganisms, especially Clostridium species.
HARDY DIAGNOSTICS
AG19H
In Commercial Distribution

  • 00819398021463 ()
  • 00819398021470 ()
AG19H

  • Enriched broth culture medium IVD

N/A - 00819398021135

Thioglycollate with H & K, 8mL, 16x100mm tube, 20 tubes.box (Thioglycollate without indicator with hemin and vitamin K) For the cultivation of bacteria, including fastidious anaerobes. Filtered to remove dead bacteria and debris.
HARDY DIAGNOSTICS
K234
In Commercial Distribution

  • 00819398021128 ()
  • 00819398021135 ()
K234

  • Enriched broth culture medium IVD

N/A - 00819398021074

Thioglycollate with H & K, 16x100mm Tube, 5ml. Hardy Diagnostics Thioglycollate Media is recommended for the cultivation of aerobic, microaerophilic, and anaerobic microorganisms.
HARDY DIAGNOSTICS
K22
In Commercial Distribution

  • 00819398021067 ()
  • 00819398021074 ()
K22

  • Enriched broth culture medium IVD

N/A - 00819398021050

Cooked Meat Medium, 20x125mm Tube, 15ml. Hardy Diagnostics Cooked Meat Medium is recommended for the cultivation of aerobic, microaerophilic, and anaerobic microorganisms, especially Clostridium species.
HARDY DIAGNOSTICS
K219
In Commercial Distribution

  • 00819398021043 ()
  • 00819398021050 ()
K219

  • Enriched broth culture medium IVD

N/A - 00819398020992

Cooked Meat Medium, 16x125mm Tube, 10ml. Hardy Diagnostics Cooked Meat Medium is recommended for the cultivation of aerobic, microaerophilic, and anaerobic microorganisms, especially Clostridium species.
HARDY DIAGNOSTICS
K19
In Commercial Distribution

  • 00819398020985 ()
  • 00819398020992 ()
K19

  • Enriched broth culture medium IVD

N/A - 00819398020916

Buffered Yeast Extract, 16x125mm Tube, 10mL. Hardy Diagnostics Buffered Yeast Extract (BYE) broth is recommended for use in the cultivation of Legionella spp. in water and other samples suspected of harboring the bacteria.
HARDY DIAGNOSTICS
K159
Not in Commercial Distribution

  • 00819398020909 ()
  • 00819398020916 ()
K159

  • Enriched broth culture medium IVD

N/A - 00819398020657

BHI Broth with Fildes, 16x125mm Tube, 10ml. Brain Heart Infusion (BHI) Broth enriched with Fildes is useful for cultivating capsular strains of Haemophilusinfluenzae.
HARDY DIAGNOSTICS
K08
In Commercial Distribution

  • 00819398020640 ()
  • 00819398020657 ()
K08

  • Enriched broth culture medium IVD

N/A - 00819398020633

Alkaline Peptone Water, 8mL, 16x125mm tube, 20 tubes/box An enrichment medium for the cultivation of Vibrio spp. from feces and other materials.
HARDY DIAGNOSTICS
K03
In Commercial Distribution

  • 00819398020626 ()
  • 00819398020633 ()
K03

  • Enriched broth culture medium IVD

N/A - 00819398020565

Middlebrook 7H9 Broth, 125ml. Hardy Diagnostics Middlebrook 7H9 Broth are recommended for use in the cultivation of Mycobacterium spp. Product is light sensitive.
HARDY DIAGNOSTICS
C24
In Commercial Distribution

  • 00819398020558 ()
  • 00819398020565 ()
C24

  • Enriched broth culture medium IVD

N/A - 00819398020510

Middlebrook 7H9 Broth with Tween® 80, 16x125mm Tube, 5ml. 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
C62
In Commercial Distribution

  • 00819398020503 ()
  • 00819398020510 ()
C62

  • Enriched broth culture medium IVD

N/A - 00819398020336

Middlebrook 7H10 with Human Blood, 10ml Slant. Hardy Diagnostics Middlebrook 7H10 Agar with Human Blood is recommended for use in the isolation and cultivation of Mycobacterium spp., including M. genavense.
HARDY DIAGNOSTICS
C42
In Commercial Distribution

  • 00819398020329 ()
  • 00819398020336 ()
C42

  • Enriched agar culture medium IVD

N/A - 00819398020299

Middlebrook 7H11 Slant, 20x125 tube, 100 tubes/box For the cultivation of Mycobacterium spp.
HARDY DIAGNOSTICS
C36BX
In Commercial Distribution

  • 00819398020282 ()
  • 00819398020299 ()
C36BX

  • Enriched agar culture medium IVD

N/A - 00819398020275

Middlebrook 7H10 Agar, 20x125mm Tube, 10ml Slant. Hardy Diagnostics Middlebrook 7H10 Agar is recommended for use in qualitative procedures for the isolation and cultivation of Mycobacterium species.
HARDY DIAGNOSTICS
C34
In Commercial Distribution

  • 00819398020268 ()
  • 00819398020275 ()
C34

  • Enriched agar culture medium IVD

AnaeroGRO - 00819398020091

Thioglycollate with H and K, 16x125mm Tube with Hungate Septum Cap, 7ml. Hardy Diagnostics AnaeroGRO™ Thioglycollate with Hemin and Vitamin K (H and K) is recommended for the cultivation of microaerophilic, facultative and obligate anaerobic microorganisms.
HARDY DIAGNOSTICS
AG23H
In Commercial Distribution

  • 00819398020084 ()
  • 00819398020091 ()
AG23H

  • Enriched broth culture medium IVD

AnaeroGRO - 00819398020077

Thioglycollate with H and K, 16x125mm Tube with Hungate Septum Cap, 9ml. Hardy Diagnostics AnaeroGRO™ Thioglycollate with Hemin and Vitamin K (H and K) is recommended for the cultivation of microaerophilic, facultative and obligate anaerobic microorganisms.
HARDY DIAGNOSTICS
AG22H
In Commercial Distribution

  • 00819398020060 ()
  • 00819398020077 ()
AG22H

  • Enriched broth culture medium IVD

AnaeroGRO - 00819398020053

Chopped Meat Broth, 16x125mm Tube with Hungate Septum Cap, 9ml. Hardy Diagnostics AnaeroGRO™ Chopped Meat Media is recommended for the cultivation of microaerophilic, facultative and obligate anaerobic microorganisms, especially Clostridium species.
HARDY DIAGNOSTICS
AG21H
In Commercial Distribution

  • 00819398020046 ()
  • 00819398020053 ()
AG21H

  • Enriched broth culture medium IVD

AnaeroGRO - 00819398020039

Chopped Meat Carbohydrate Broth, 16x125mm Tube with Hungate Septum Cap, 9ml. Hardy Diagnostics AnaeroGRO™ Chopped Meat Media is recommended for the cultivation of microaerophilic, facultative and obligate anaerobic microorganisms, especially Clostridium species.
HARDY DIAGNOSTICS
AG20H
In Commercial Distribution

  • 00819398020022 ()
  • 00819398020039 ()
AG20H

  • Enriched broth culture medium IVD

Mucolyse (Inner-100 mg) - 10628429001001

PRO-LAB Mucolyse is a sputum liquefying agent used to digest and thin out the sputum, thus enhancing the isolation of organisms responsible for chronic lung disease
PRO-LAB, INCORPORATED
PL.701
In Commercial Distribution

  • 10628429001001 ()
PL.701

  • Sputum liquefaction/decontamination reagent IVD

Alpha-Tec Systems - 00816085024073

NAC-PAC EA3 (3.0%) w/ NALC powder
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085024059 ()
  • 00816085024073 ()
0004813

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085024066

NAC-PAC EA3 (2.5%) w/ NALC powder
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085024042 ()
  • 00816085024066 ()
0004819

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085024059

NAC-PAC EA3 (3.0%) tray w/ NALC powder
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085024059 ()


  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085024042

NAC-PAC EA3 (2.5%) tray w/ NALC powder
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085024042 ()


  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085023793

Triton X-100 20%
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023793 ()
0003358

  • Faecal parasite specimen concentration kit IVD

Alpha-Tec Systems - 00816085023786

Triton X-100 20%
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023786 ()
X000401

  • Faecal parasite specimen concentration kit IVD

Alpha-Tec Systems - 00816085023373

NAC-PAC (3.0%) 200ml bottle
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023373 ()


  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085023366

NAC-PAC (2.5%) 50ml bottle
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023366 ()


  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085023359

NAC-PAC (3.0%) 5x200ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023373 ()
  • 00816085023359 ()
0003499

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085023342

M/15 Phosphate Buffer 50x40ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023342 ()
0003496

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085023243

NAC-PAC (4.0%) 50ml bottle
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023243 ()


  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085023236

NAC-PAC (2.5%) 200ml bottle
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023236 ()


  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085023229

NAC-PAC (4.0%) 200ml bottle
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085023229 ()


  • Sputum specimen liquefaction/decontamination kit IVD
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