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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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Alpha-Tec Systems - 00816085021768

Oxalic Acid 20x5ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021768 ()
0003435

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085021614

OxA Oxalic Acid Reagent Kit
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021621 ()
  • 00816085021614 ()
0004805

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085020990

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

  • 00816085021065 ()
  • 00816085020990 ()
0004309

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085020983

NAC-PAC RED (4.0%) 5x200ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021058 ()
  • 00816085020983 ()
0004308

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085020976

NAC-PAC RED (2.0%) 5x200ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021041 ()
  • 00816085020976 ()
0004307

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085020969

NAC-PAC RED (2.5%) 5x200ml
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021034 ()
  • 00816085020969 ()
0004306

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085020709

M/15 Phosphate Buffer 500ml bottle
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085020709 ()
X003451

  • Sputum specimen liquefaction/decontamination kit IVD

Alpha-Tec Systems - 00816085020631

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

  • 00816085020266 ()
  • 00816085020631 ()
0004303

  • Sputum specimen liquefaction/decontamination kit IVD

CLINICAL HEALTH SERVICES, INC. - 00815290013872

Ultrasound Lotion, Gallon with Dispenser
CLINICAL HEALTH SERVICES, INC.
CLID373X-Lotion
In Commercial Distribution

  • 00815290013872 ()
  • 00815290015012 ()
CLID373X-Lotion

  • Skin topical coupling gel

N/A - 00816576027910

BCYE Agar / BCYE Agar without Cysteine, 15x100mm Biplate, 12ml/12ml. Hardy Diagnostics Buffered Charcoal Yeast Extract (BCYE) Agar formulations are recommended for use in the cultivation and primary isolation of Legionella spp. in water and other samples suspected of harboring the bacteria. BCYE without Cysteine is for use in conjunction with BCYE Agar containing L-Cysteine for identification of Legionella spp. from clinical and environmental sources.
HARDY DIAGNOSTICS
J61
In Commercial Distribution

  • 00816576027903 ()
  • 00816576027910 ()
J61

  • Enriched agar culture medium IVD

N/A - 00816576026197

Blood Agar 5%, 15x100mm Plate, 19ml (reduced stacking ring). Hardy Diagnostics Blood Agar products are recommended for use as general purpose growth media for the isolation, cultivation, and differentiation of a wide variety of microorganisms.
HARDY DIAGNOSTICS
GA10
In Commercial Distribution

  • 00816576026180 ()
  • 00816576026197 ()
GA10

  • Enriched agar culture medium IVD

N/A - 00816576026111

Wilkins-Chalgren Agar, 15x100mm Plate, 18ml. Hardy Diagnostics Wilkins-Chalgren Agar is recommended for the cultivation and isolation of anaerobic microorganisms and for the preparation of agar dilution tests.
HARDY DIAGNOSTICS
G89
In Commercial Distribution

  • 00816576026104 ()
  • 00816576026111 ()
G89

  • Enriched agar culture medium IVD

N/A - 00816576024773

BCYE Agar, 15x100mm Plate, 18ml. Hardy Diagnostics Buffered Charcoal Yeast Extract (BCYE) Agar formulations are recommended for use in the cultivation and primary isolation of Legionella spp. in water and other samples suspected of harboring the bacteria. BCYE without Cysteine is for use in conjunction with BCYE Agar containing L-Cysteine for identification of Legionella spp. from clinical and environmental sources.
HARDY DIAGNOSTICS
G07
In Commercial Distribution

  • 00816576024766 ()
  • 00816576024773 ()
G07

  • Enriched agar culture medium IVD

N/A - 00816576024629

Chocolate Agar, 15x100 monoplate, 100 plates/box (GC Agar Base with 1% hemoglobin and enrichments) For the cultivation of fastidious bacteria.
HARDY DIAGNOSTICS
E14BX
In Commercial Distribution

  • 00816576024605 ()
  • 00816576024629 ()
E14BX

  • Enriched agar culture medium IVD

N/A - 00816576024612

Chocolate Agar, 15x100 monoplate, 10/pk (GC Agar Base with 1% hemoglobin and enrichments) For the cultivation of fastidious bacteria.
HARDY DIAGNOSTICS
E14
In Commercial Distribution

  • 00816576024605 ()
  • 00816576024612 ()
E14

  • Enriched agar culture medium IVD

AnaeroGRO - 00816576024469

Brucella Agar with Hemin and Vitamin K 4Pak, Monoplate. Hardy Diagnostics AnaeroGRO™ Brucella Agar with Hemin and Vitamin K is recommended for use in the primary isolation, quantitation, and partial identification of obligately anaerobic microorganisms from clinical specimens. This non-selective medium is also suitable for the growth of aerobic and microaerophilic bacteria when incubated under the appropriate conditions.
HARDY DIAGNOSTICS
AG304
In Commercial Distribution

  • 00816576024421 ()
  • 00816576024469 ()
AG304

  • Enriched agar culture medium IVD

AnaeroGRO - 00816576024438

Brucella Agar with Hemin and Vitamin K, Monoplate. Hardy Diagnostics AnaeroGRO™ Brucella Agar with Hemin and Vitamin K is recommended for use in the primary isolation, quantitation, and partial identification of obligately anaerobic microorganisms from clinical specimens. This non-selective medium is also suitable for the growth of aerobic and microaerophilic bacteria when incubated under the appropriate conditions.
HARDY DIAGNOSTICS
AG301
In Commercial Distribution

  • 00816576024438 ()
AG301

  • Enriched agar culture medium IVD

N/A - 00816576024315

V Agar with CNA , 15x100mm Plate, 17ml. Hardy Diagnostics V Agar is an enriched media used for the isolation and differentiation of Gardnerella vaginalis.
HARDY DIAGNOSTICS
A81
In Commercial Distribution

  • 00816576024308 ()
  • 00816576024315 ()
A81

  • Enriched agar culture medium IVD

N/A - 00816576024292

V Agar, 15x100mm Plate, 17ml. Hardy Diagnostics V Agar is an enriched media used for the isolation and differentiation of Gardnerella vaginalis.
HARDY DIAGNOSTICS
A80
In Commercial Distribution

  • 00816576024285 ()
  • 00816576024292 ()
A80

  • Enriched agar culture medium IVD

N/A - 00816576024216

RTF Agar (Modified Casman), 15x100mm Plate, 17ml. Hardy Diagnostics RTF Agar is recommended for the cultivation and differentiation of fastidious microorganisms, especially Haemophilus spp. by hemolytic reaction.
HARDY DIAGNOSTICS
A68
In Commercial Distribution

  • 00816576024209 ()
  • 00816576024216 ()
A68

  • Enriched agar culture medium IVD

N/A - 00816576024018

Brucella Agar with H & K,15x100mm Plate, 19ml. Hardy Diagnostics Brucella Agar with H & K is recommended for use in the primary isolation and cultivation of anaerobic microorganisms.
HARDY DIAGNOSTICS
A30
In Commercial Distribution

  • 00816576024001 ()
  • 00816576024018 ()
A30

  • Enriched agar culture medium IVD

N/A - 00816576023974

BHI Agar with Blood, 15x100mm Plate, 18ml. Hardy Diagnostics Brain Heart Infusion (BHI) Agar is a general purpose nutrient medium recommended for the cultivation and isolation of a variety of microorganisms, including bacteria, yeasts, and molds. The addition of defibrinated sheep blood and antimicrobics produces a selective medium used for the isolation of pathogenic fungi from specimens heavily contaminated with bacteria and saprophytic fungi.
HARDY DIAGNOSTICS
A20
In Commercial Distribution

  • 00816576023967 ()
  • 00816576023974 ()
A20

  • Enriched agar culture medium IVD

N/A - 00816576023950

Blood Agar, 8%, 15x100 monoplate, 10 pks of 10 (Tryptic Soy Agar with 8% Sheep Blood) For the cultivation of microorganisms.
HARDY DIAGNOSTICS
A17BX
In Commercial Distribution

  • 00816576023943 ()
  • 00816576023950 ()
A17BX

  • Enriched broth culture medium IVD

N/A - 00816576023929

Columbia Blood Agar, 15x100 monoplate, 10 pks of 10 IColumbia Agar Base with 5% Sheep Blood). For the cultivation of microorganisms.
HARDY DIAGNOSTICS
A16BX
In Commercial Distribution

  • 00816576023905 ()
  • 00816576023929 ()
A16BX

  • Enriched broth culture medium IVD

N/A - 00816576023912

Columbia Blood Agar, 15x100 monoplate, 10/pk (Columbia Agar Base with 5% Sheep Blood) For the cultivation of microorganisms.
HARDY DIAGNOSTICS
A16
In Commercial Distribution

  • 00816576023905 ()
  • 00816576023912 ()
A16

  • Enriched agar culture medium IVD

N/A - 00816576023875

Horse Blood Agar 5%, 15x100mm Plate, 17ml. Hardy Diagnostics Horse Blood Agar is an enriched all-purpose growth medium recommended for the cultivation of nonfastidious and fastidious microorganisms such as Haemophilus spp.
HARDY DIAGNOSTICS
A149
In Commercial Distribution

  • 00816576023868 ()
  • 00816576023875 ()
A149

  • Enriched agar culture medium IVD

N/A - 00816576023752

Blood Agar Plate, 15x100, 10pks of 10 (Tryptic Soy Agar with 5% Sheep Blood) For the cultivation of microorganisms.
HARDY DIAGNOSTICS
A10BX
In Commercial Distribution

  • 00816576023738 ()
  • 00816576023752 ()
A10BX

  • Enriched agar culture medium IVD

N/A - 00816576023745

Blood Agar, 5%, 15x100, 10/pk (Tryptic Soy Agar with 5% Sheep Blood) For the cultivation of microorganisms
HARDY DIAGNOSTICS
A10
In Commercial Distribution

  • 00816576023738 ()
  • 00816576023745 ()
A10

  • Enriched agar culture medium IVD

N/A - 00816576023721

Blood Agar EH, 5%, 15x100mm Plate, 17ml Hardy Diagnostics Blood Agar Enhanced Hemolysis (EH) is recommended for use as a general purpose growth medium for the isolation, cultivation, and differentiation of fastidious microorganisms from specimens where clear and distinct hemolytic reactions are of prime importance.
HARDY DIAGNOSTICS
A03
In Commercial Distribution

  • 00816576023714 ()
  • 00816576023721 ()
A03

  • Enriched agar culture medium IVD

N/A - 00816576023585

TSA Blood 5%/TSA Blood 5%, 15x100, Biplate, 10/pk TSA with 5% Sheep Blood Biplate. For the cultivation of microorganisms.
HARDY DIAGNOSTICS
200B
Not in Commercial Distribution

  • 00816576023578 ()
  • 00816576023585 ()
200B

  • Enriched agar culture medium IVD

N/A - 00816576028955

Carbon Dioxide (CO2) Tablet Each tablet is individually sealed in a ten-pack foil pouch. Supplied with ten zip lock bags.
HARDY DIAGNOSTICS
CO2BAG
In Commercial Distribution

  • 00816576028955 ()
CO2BAG

  • Atmospheric generation IVD, control

N/A - 00816576027477

Brucella Blood Agar with Hemin, and Vitamin K, 15x100mm plate, 26ml fill, order by the package of 10 (Brucella Agar with Hemin & Vitamin K) For the cultivation of anaerobes. A non-inhibitory general growth medium for all gram positive and gram negative anaerobic bacteria. Optimized formula for enhanced growth characteristics of anaerobes.
HARDY DIAGNOSTICS
W23
In Commercial Distribution

  • 00816576027460 ()
  • 00816576027477 ()
W23

  • Enriched agar culture medium IVD

N/A - 00816576027248

Blood Agar 5% / Blood Agar 5%, 15x100mm Biplate, 10ml/10ml. Hardy Diagnostics Blood Agar products are recommended for use as general purpose growth media for the isolation, cultivation, and differentiation of a wide variety of microorganisms.
HARDY DIAGNOSTICS
J93
In Commercial Distribution

  • 00816576027231 ()
  • 00816576027248 ()
J93

  • Enriched agar culture medium IVD

N/A - 00816576026869

Blood Agar, 5% / Chocolate Agar, 15x100mm Biplate, 10ml/10ml. Hardy Diagnostics Blood Agar products are recommended for use as general purpose growth media for the isolation, cultivation, and differentiation of a wide variety of microorganisms. Hardy Diagnostics Chocolate Agar is recommended for use in the isolation and cultivation of fastidious microorganisms, particularly Haemophilus and Neisseria species.
HARDY DIAGNOSTICS
J42
In Commercial Distribution

  • 00816576026852 ()
  • 00816576026869 ()
J42

  • Multiple formulation agar culture medium IVD

N/A - 00816576026319

Blood Agar 5%, 15x150mm Plate, 70ml. Hardy Diagnostics Blood Agar products are recommended for use as general purpose growth media for the isolation, cultivation, and differentiation of a wide variety of microorganisms.
HARDY DIAGNOSTICS
H28
In Commercial Distribution

  • 00816576026302 ()
  • 00816576026319 ()
H28

  • Enriched agar culture medium IVD

N/A - 00816576026296

Chocolate Agar, 15x150mm Plate, 69ml. Hardy Diagnostics Chocolate Agar is recommended for use in the isolation and cultivation of fastidious microorganisms, particularly Haemophilus and Neisseria species.
HARDY DIAGNOSTICS
H25
In Commercial Distribution

  • 00816576026289 ()
  • 00816576026296 ()
H25

  • Enriched agar culture medium IVD

N/A - 00816576026272

Brucella Agar with H & K, 15x150mm Plate, 69ml. Hardy Diagnostics Brucella Agar with H & K is recommended for use in the primary isolation and cultivation of anaerobic microorganisms.
HARDY DIAGNOSTICS
H05
In Commercial Distribution

  • 00816576026265 ()
  • 00816576026272 ()
H05

  • Enriched agar culture medium IVD

N/A - 00816576024872

BCYE Agar without Cysteine, 15x100mm Plate, 18ml. Hardy Diagnostics Buffered Charcoal Yeast Extract (BCYE) Agar formulations are recommended for use in the cultivation and primary isolation of Legionella spp. in water and other samples suspected of harboring the bacteria. BCYE without Cysteine is for use in conjunction with BCYE Agar containing L-Cysteine for identification of Legionella spp. from clinical and environmental sources.
HARDY DIAGNOSTICS
G108
In Commercial Distribution

  • 00816576024865 ()
  • 00816576024872 ()
G108

  • Enriched agar culture medium IVD

N/A - 00816576024377

Schaedler's Agar with H&K, 15x100, monoplate, 10/pk (Schaedler's Agar with Hemin, Vitamin K, and 5% Sheep Blood) For the cultivation of anaerobic bacteria.
HARDY DIAGNOSTICS
A98
In Commercial Distribution

  • 00816576024360 ()
  • 00816576024377 ()
A98

  • Enriched agar culture medium IVD

N/A - 00816576024254

Blood Agar 10%, 15x100mm Plate, 18ml. Hardy Diagnostics Blood Agar products are recommended for use as general purpose growth media for the isolation, cultivation, and differentiation of a wide variety of microorganisms.
HARDY DIAGNOSTICS
A71
In Commercial Distribution

  • 00816576024247 ()
  • 00816576024254 ()
A71

  • Enriched agar culture medium IVD
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