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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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All Purpose Quad Plate (Eosine Methylene Blue (EMB) Agar / Mannitol Salt Agar (MSA) / Mycobiotic Agar / Blood Agar, 5%), 15x100mm Quadplate, 5ml/section. 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 EMB Agar formulations are recommended for use as selective and differential media for the isolation of gram-negative bacilli (including coliform organisms and enteric pathogens) from clinical and nonclinical specimens. Hardy Diagnostics Mannitol Salt Agar (MSA) is recommended for use as a selective and differential medium for the isolation of pathogenic staphylococci. Hardy Diagnostics Mycobiotic Agar is recommended for use in the isolation of pathogenic fungi from clinical specimens.
HARDY DIAGNOSTICS
J79
In Commercial Distribution

  • 00816576028078 ()
  • 00816576028085 ()
J79

  • Multiple formulation agar culture medium IVD
Urine Quad Plate (EMB/Modified XLD/Simmons Citrate/Blood Agar, 5%), 15x100mm Plate, 20ml. 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 EMB Agar formulations are recommended for use as selective and differential media for the isolation of gram-negative bacilli (including coliform organisms and enteric pathogens) from clinical and nonclinical specimens. Hardy Diagnostics Simmons Citrate Agar is recommended for use in the differentiation of gram-negative enteric bacilli based on citrate utilization. Hardy Diagnostics XLD Agar with Novobiocin is recommended for use as a selective and differential medium for the isolation of gram-negative enteric pathogens from foods or other samples. Modified XLD Agar is recommended for use as a selective and differential medium for the isolation of gram-negative enteric pathogens from specimens.
HARDY DIAGNOSTICS
J71
In Commercial Distribution

  • 00816576027989 ()
  • 00816576028061 ()
J71

  • Multiple formulation agar culture medium IVD
MultiPak A, BRU with Hemin and Vitamin K, Monoplate; PEA, Monoplate; BBE/LKV, Biplate. 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
AG303
In Commercial Distribution

  • 00816576024452 ()
AG303

  • Multiple formulation agar culture medium IVD
  • Enriched agar culture medium IVD
  • Differential/selective agar culture medium IVD
Urine Quad Plate, 15x100, Quadplate, 10/pk Used for the isolation and differentiation of microorganisms found in urine specimens. Quad 1: EMB, Levine Quad 2: Modified XLD Agar Quad 3: Simmons Citrate Quad 4: TSA with 5% Sheep Blood
HARDY DIAGNOSTICS
4001NF
In Commercial Distribution

  • 00816576023691 ()
  • 00816576023707 ()
4001NF

  • Multiple formulation agar culture medium IVD
Quad General Plate, 15x100, Quadplate, 10/pk For use in the isolation and differentiation of microorganisms. Section I: EMB Agar Section II: TSA Blood Agar 5% Section III: Staph Selective Agar Section IV: Mycobiotic Agar
HARDY DIAGNOSTICS
4000
Not in Commercial Distribution

  • 00816576023677 ()
  • 00816576023684 ()
4000

  • Multiple formulation agar culture medium IVD
MNS/MAC/TSA w/Blood, 15x100, Triplate, 10/pk For use in the isolation and differentiation of microorganisms Section I: MNS (Mannitol Salt Agar) Section II: MAC (MacConkey Agar) Section III: TSA Blood
HARDY DIAGNOSTICS
3002
Not in Commercial Distribution

  • 00816576023653 ()
  • 00816576023660 ()
3002

  • Multiple formulation agar culture medium IVD
EMB/TSA with Blood/Staph Select, 15x100, Triplate, 10/pk For cultivation and differentiation of microorganisms Section I: ECM Levine Agar Section II: TSA with 5% Sheep Blood Section III: Staph Selective
HARDY DIAGNOSTICS
3001
Not in Commercial Distribution

  • 00816576023639 ()
  • 00816576023646 ()
3001

  • Multiple formulation agar culture medium IVD
DuoPak B, BRU with Hemin and Vitamin K, Monoplate; BBE/PEA, Biplate. 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
AG312
In Commercial Distribution

  • 00816576024476 ()
AG312

  • Multiple formulation agar culture medium IVD
  • Enriched agar culture medium IVD
DuoPak A, BRU with Hemin and Vitamin K, Monoplate; BBE/LKV, Biplate. 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
AG302
In Commercial Distribution

  • 00816576024445 ()
AG302

  • Multiple formulation agar culture medium IVD
  • Enriched agar culture medium IVD
AS-444 BRU, PEA, BBE, and LKV Convenience Pack - Includes 1 Brucella Blood Agar (BRU), 1 Phenylethyl Alcohol Blood Agar, 1 Bacteroides Bile Esculin Agar (BBE), and 1 Laked Brucella Blood Agar with Kanamycin and Vancomycin (LKV). Pre-reduced anaerobically sterilized (PRAS). 100 x 15 mm agar plate. BRU is opaque burgundy red. PEA is opaque red. BBE is transparent yellow/green. LKV is transparent red. 4 plates per pack.
ANAEROBE SYSTEMS
AS-444
In Commercial Distribution

  • 00810048901333 ()
AS-444

  • Multiple formulation agar culture medium IVD
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