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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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Bioteke Corporation (Wuxi) Co., Ltd.
ST7001-2
In Commercial Distribution

  • 86974541563044 ()
  • 06974541563048 ()


  • General specimen collection kit IVD, clinical
No Description
Bioteke Corporation (Wuxi) Co., Ltd.
ST7001-1
In Commercial Distribution

  • 86974541563020 ()
  • 06974541563031 ()


  • General specimen collection kit IVD, clinical
No Description
Bioteke Corporation (Wuxi) Co., Ltd.
ST7001-1
In Commercial Distribution

  • 06974541563024 ()
  • 86974541563020 ()


  • General specimen collection kit IVD, clinical
Vial With Solution
DEROYAL INDUSTRIES, INC.
31-VIAL19
In Commercial Distribution

  • 50749756372744 ()
  • 00749756372749 ()
31-VIAL19

  • Surgical suction system collection container, single-use
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
AS-846 Peptone Yeast Extract Broth with Lactate (PY LACTATE) is designed for the determination of lactate fermentation 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-846
In Commercial Distribution

  • 00810048902484 ()
  • 00810048902491 ()
AS-846

  • Basic/simple nutrient broth culture medium IVD
AS-858 Peptone Yeast Extract Broth with Glucose and Formate/Fumarate (PYG FF) is designed for the determination of glucose fermentation and formate/fumarate stimulation by anaerobic bacteria for identification. Pre-reduced anaerobically sterilized (PRAS). 10 mL fill volume. 16 x 100 mm hungate-capped tubes. Transparent golden yellow liquid. 10 tubes per pack.
ANAEROBE SYSTEMS
AS-858
In Commercial Distribution

  • 00810048902460 ()
  • 00810048902477 ()
AS-858

  • Basic/simple nutrient broth culture medium IVD
AS-8215 Peptone Yeast Extract Broth (PY) is an enriched non-selective broth media used in the growth and partial identification of anaerobic bacteria based on their specific biochemical features. Pre-reduced anaerobically sterilized (PRAS). 500 mL fill volume. 500 mL Pyrex bottle. Transparent light yellow liquid. 1 bottle per pack.
ANAEROBE SYSTEMS
AS-8215
In Commercial Distribution

  • 00810048901418 ()
AS-8215

  • Basic/simple nutrient broth culture medium IVD
AS-8212 Peptone Yeast Extract Broth (PY) is an enriched non-selective broth media used in the growth and partial identification of anaerobic bacteria based on their specific biochemical features. Pre-reduced anaerobically sterilized (PRAS).250 mL fill volume. 250 mL Pyrex bottle. Transparent light yellow liquid. 1 bottle per pack.
ANAEROBE SYSTEMS
AS-8212
In Commercial Distribution

  • 00810048901401 ()
AS-8212

  • Basic/simple nutrient broth culture medium IVD
AS-810 Brucella Agar Deep 18 mL (BRU DEEP 18mL), with the addition of blood, is intended for the isolation, quantitation, and partial identification of obligate anaerobic bacteria from clinical specimens. This media will support the growth of aerobic and microaerophilic bacteria if incubated appropriately. Pre-reduced anaerobically sterilized (PRAS). 18 mL fill volume. 20 x 113 mm screw top tube. Translucent yellow. 10 tubes per pack.
ANAEROBE SYSTEMS
AS-810
In Commercial Distribution

  • 00810048901890 ()
  • 00810048901395 ()
AS-810

  • Basic/simple nutrient agar culture medium IVD
AS-809 Brucella Agar Deep CLSI 17 mL (BRU DEEP CLSI 17mL), with the addition of blood, is intended for the isolation, quantitation, and partial identification of obligate anaerobic bacteria from clinical specimens. This media will support the growth of aerobic and microaerophilic bacteria if incubated appropriately. Pre-reduced anaerobically sterilized (PRAS). 17 mL fill volume. 20 x 113 mm screw top tube. Translucent yellow. 10 tubes per pack.
ANAEROBE SYSTEMS
AS-809
In Commercial Distribution

  • 00810048901883 ()
  • 00810048901388 ()
AS-809

  • Basic/simple nutrient agar culture medium IVD
AS-808 Brucella Agar Deep CLSI 19 mL (BRU DEEP CLSI 19mL), with the addition of blood, is intended for the isolation, quantitation, and partial identification of obligate anaerobic bacteria from clinical specimens. This media will support the growth of aerobic and microaerophilic bacteria if incubated appropriately. Pre-reduced anaerobically sterilized (PRAS). 19 mL fill volume. 20 x 113 mm screw top tube. Translucent yellow. 10 tubes per pack.
ANAEROBE SYSTEMS
AS-808
In Commercial Distribution

  • 00810048901876 ()
  • 00810048901371 ()
AS-808

  • Basic/simple nutrient agar culture medium IVD
AS-6425 Bacteroides vulgatus Selective Agar (BVSA) is an enriched selective and differential media for the isolation and presumptive identification of obligately anaerobic gram-negative bacilli of the Bacteroides fragilis group. Pre-reduced anaerobically sterilized (PRAS). 100 x 15 mm agar plates. Transparent yellow/green. 4 plates per pack.
ANAEROBE SYSTEMS
AS-6425
In Commercial Distribution

  • 00810048901692 ()
  • 00810048901364 ()
AS-6425

  • Differential/selective agar culture medium IVD
AS-6424 Cadmium Sulfate Fluoride Acriflavine Tellurite Agar (CFAT) is an enriched selective media formulated for the enhanced isolation of Actinomyces naeslundii and Actinomyces viscosus from a mixed culture. Pre-reduced anaerobically sterilized (PRAS). 100 x 15 mm agar plate. Opaque red. 4 plates per pack.
ANAEROBE SYSTEMS
AS-6424
In Commercial Distribution

  • 00810048901685 ()
  • 00810048901357 ()
AS-6424

  • Differential/selective agar culture medium IVD
AS-6420 Campylobacter-Wolinella Differential Medium (CAMPY-WOL) is an enriched, selective, and differential media used for the isolation and presumptive identification of anaerobic Campylobacter species. Pre-reduced anaerobically sterilized (PRAS). 100 x 15 mm agar plate. Transparent light yellow/green. 4 plates per pack.
ANAEROBE SYSTEMS
AS-6420
In Commercial Distribution

  • 00810048901647 ()
  • 00810048901340 ()
AS-6420

  • Differential/selective agar culture medium IVD
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
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
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
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
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
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