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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 - 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

BD BBL™ Mueller Hinton Chocolate Agar - 10382902218026

BD BBL™ Mueller Hinton Chocolate Agar
BECTON, DICKINSON AND COMPANY
221802
Not in Commercial Distribution

  • 10382902218026 ()
  • 00382902218029 ()
  • 30382902218020 ()

  • Outer Diameter: 150 Millimeter
  • Depth: 15 Millimeter
221802

  • Differential/selective agar culture medium IVD

BD BBL™ Trypticase™ Soy Broth with 20% Glycerol - 30382902978085

BD BBL™ Trypticase™ Soy Broth with 20% Glycerol, Ctn. of 100 size K tubes
BECTON, DICKINSON AND COMPANY
297808
In Commercial Distribution

  • 30382902978085 ()
  • 00382902978084 ()

  • Total Volume: 1.5 Milliliter
297808

  • Basic/simple nutrient broth culture medium IVD

BD BBL™ Selenite Cystine Broth - 30382902977118

Tube Selenite Cystine Broth 20 Ml 100 Ea
BECTON, DICKINSON AND COMPANY
297711
Not in Commercial Distribution

  • 30382902977118 ()
  • 00382902977117 ()

  • Total Volume: 20 Milliliter
297711

  • Differential/selective broth culture medium IVD

Vacuette - 29120049208658

VACUETTE® 3 ml Virus Stabilization Tube 13x100 red cap-white ring, PREMIUM, USA
Greiner Bio-One GmbH
456164
In Commercial Distribution

  • 39120049208655 ()
  • 29120049208658 ()
  • 19120049208651 ()
456164

  • General tissue specimen container IVD, fixative/saline

Vacuette - 29120049208641

VACUETTE® 2 ml Virus Stabilization Tube 13x100 red cap-white ring, PREMIUM, USA
Greiner Bio-One GmbH
456163
Not in Commercial Distribution

  • 39120049208648 ()
  • 29120049208641 ()
  • 19120049208644 ()
456163

  • General tissue specimen container IVD, fixative/saline

PRAS Peptone Yeast Extract Broth w/ Glucose & Tween 80 (PYG TWEEN) - 00810048902514

AS-825 Peptone Yeast Extract Broth with Glucose and Tween 80 (PYG TWEEN) is designed for the determination of glucose fermentation and Tween 80 stimulation by anaerobic bacteria for identification. Pre-reduced anaerobically sterilized (PRAS). 10 mL fill volume. 16 x 100 mm hungate-capped tube. Transparent golden yellow liquid. 10 tubes per pack.
ANAEROBE SYSTEMS
AS-825
In Commercial Distribution

  • 00810048902507 ()
  • 00810048902514 ()
AS-825

  • Basic/simple nutrient broth culture medium IVD

PRAS Dilution Blanks - 00810048901234

AS-918-500 Dilution Blanks are a buffered mineral salt base solution with reducing agents, designed as a holding medium for maintaining viability of microorganisms, especially anaerobes, in order to determine the number of viable organisms present in a sample. Pre-reduced anaerobically sterilized (PRAS). 500 mL fill volume. 500 mL Pyrex bottle. Transparent colorless liquid. 1 bottle per pack.
ANAEROBE SYSTEMS
AS-918-500
In Commercial Distribution

  • 00810048901234 ()
AS-918-500

  • Buffered sample diluent IVD, manual

PRAS Dilution Blanks - 00810048901227

AS-9183 Dilution Blanks are a buffered mineral salt base solution with reducing agents, designed as a holding medium for maintaining viability of microorganisms, especially anaerobes, in order to determine the number of viable organisms present in a sample. Pre-reduced anaerobically sterilized (PRAS). 250 mL fill volume. 250 mL Pyrex bottle. Transparent colorless liquid. 1 bottle per pack.
ANAEROBE SYSTEMS
AS-9183
In Commercial Distribution

  • 00810048901227 ()
AS-9183

  • Buffered sample diluent IVD, manual

PRAS Dilution Blanks - 00810048901210

AS-918 Dilution Blanks are a buffered mineral salt base solution with reducing agents, designed as a holding medium for maintaining viability of microorganisms, especially anaerobes, in order to determine the number of viable organisms present in a sample. Pre-reduced anaerobically sterilized (PRAS). 18 mL fill volume. 20 x 113 mm screw top tube. Transparent colorless liquid. 10 tubes per pack.
ANAEROBE SYSTEMS
AS-918
In Commercial Distribution

  • 00810048902439 ()
  • 00810048901210 ()
AS-918

  • Buffered sample diluent IVD, manual

PRAS Dilution Blanks - 00810048901203

AS-917 Dilution Blanks are a buffered mineral salt base solution with reducing agents, designed as a holding medium for maintaining viability of microorganisms, especially anaerobes, in order to determine the number of viable organisms present in a sample. Pre-reduced anaerobically sterilized (PRAS). 3 mL fill volume. 16 x 100 mm hungate-capped tube. Transparent colorless liquid. 10 tubes per pack.
ANAEROBE SYSTEMS
AS-917
In Commercial Distribution

  • 00810048902422 ()
  • 00810048901203 ()
AS-917

  • Buffered sample diluent IVD, manual

PRAS Dilution Blanks - 00810048901197

AS-910 Dilution Blanks are a buffered mineral salt base solution with reducing agents, designed as a holding medium for maintaining viability of microorganisms, especially anaerobes, in order to determine the number of viable organisms present in a sample. Pre-reduced anaerobically sterilized (PRAS). 10 mL fill volume. 16 x 100 mm hungate-capped tube. Transparent colorless liquid. 10 tubes per pack.
ANAEROBE SYSTEMS
AS-910
In Commercial Distribution

  • 00810048902385 ()
  • 00810048901197 ()
AS-910

  • Buffered sample diluent IVD, manual

PRAS Chopped Meat Medium w/ Carbohydrates (CMC) - 00810048900695

AS-8235 Chopped Meat Medium with Carbohydrates (CMC) will support the growth of most non-sporeforming and sporeforming anaerobes associated with human and animal infections. This media may be used as a maintaining or holding media for stock cultures. Pre-reduced anaerobically sterilized (PRAS). 500 mL fill volume. 500 mL Pyrex bottle. Transparent golden yellow liquid with chopped meat at the bottom. 1 bottle per pack.
ANAEROBE SYSTEMS
AS-8235
In Commercial Distribution

  • 00810048900695 ()
AS-8235

  • Enriched broth culture medium IVD

PRAS Chopped Meat Medium w/ Glucose (CMG) - 00810048900671

AS-8135 Chopped Meat Medium with Glucose (CMG) will support the growth of most non-sporeforming and sporeforming anaerobes associated with human and animal infections. This media may be used as a maintaining or holding media for stock cultures. Pre-reduced anaerobically sterilized (PRAS). 500 mL fill volume. 500 mL Pyrex bottle. Transparent golden yellow liquid with chopped meat at the bottom. 1 bottle per pack.
ANAEROBE SYSTEMS
AS-8135
In Commercial Distribution

  • 00810048900671 ()
AS-8135

  • Enriched broth culture medium IVD

PRAS Chopped Meat Medium (CM) - 00810048900657

AS-8115 Chopped Meat Medium (CM) will support the growth of most non-sporeforming and sporeforming anaerobes associated with human and animal infections. This media may be used as a maintaining or holding media for stock cultures. Pre-reduced anaerobically sterilized (PRAS). 500 mL fill volume. 500 mL Pyrex bottle. Transparent golden yellow with chopped meat at the bottom. 1 bottle per pack.
ANAEROBE SYSTEMS
AS-8115
In Commercial Distribution

  • 00810048900657 ()
AS-8115

  • Enriched broth culture medium IVD
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