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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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V Agar, Selective 10/PK
REMEL, INC.
R01952
In Commercial Distribution

  • 00848838003431 ()
R01952

  • Differential/selective agar culture medium IVD
V Agar 10/PK
REMEL, INC.
R01950
In Commercial Distribution

  • 00848838003424 ()
R01950

  • Differential/selective agar culture medium IVD
Trypan Blue Agar 10/20 (26ml) 10/PK
REMEL, INC.
R01938
In Commercial Distribution

  • 00848838003417 ()
R01938

  • Differential/selective agar culture medium IVD
TSA 15/PK
REMEL, INC.
R01921
Not in Commercial Distribution

  • 00848838003394 ()
R01921

  • General-microorganism antimicrobial susceptibility culture medium IVD
TSA 100/PK
REMEL, INC.
R01917
In Commercial Distribution

  • 00848838003363 ()
R01917

  • General-microorganism antimicrobial susceptibility culture medium IVD
Thermonuclease Agar 10/PK
REMEL, INC.
R01895
Not in Commercial Distribution

  • 00848838003325 ()
R01895

  • Differential/selective agar culture medium IVD
Tergitol 7 Agar w/TTC 10/PK
REMEL, INC.
R01875
Not in Commercial Distribution

  • 00848838003240 ()
R01875

  • Differential/selective agar culture medium IVD
TOC Agar (20ml) 10/PK
REMEL, INC.
R01870
Not in Commercial Distribution

  • 00848838003226 ()
R01870

  • Culture medium control
TCBS Agar 10/PK
REMEL, INC.
R01865
In Commercial Distribution

  • 00848838003202 ()
R01865

  • Differential/selective agar culture medium IVD
SXT Blood Agar 100/PK
REMEL, INC.
R01862
In Commercial Distribution

  • 00848838003189 ()
R01862

  • Differential/selective agar culture medium IVD
Nasal / Respiratory Specimen Collection Kit – 100 pack
KEYSTONE MANUFACTURING, LLC
KMSVKIT-KM05-100
In Commercial Distribution

  • 00860005748310 ()


  • General tissue specimen container IVD, fixative/saline
  • General-purpose absorbent tip applicator/swab, single-use
Nasal / Respiratory Specimen Collection Kit – 100 pack
KEYSTONE MANUFACTURING, LLC
KMSVKIT-KM04-100
In Commercial Distribution

  • 00860005748303 ()


  • General tissue specimen container IVD, fixative/saline
  • General-purpose absorbent tip applicator/swab, single-use
Cystine Lactose Electrolyte Deficient (CLED) Agar is used for the differentiation and enumeration of microorganisms in urine.
NEOGEN CORPORATION
2
In Commercial Distribution

  • 00860003684689 ()
NCM0034E

  • Differential/selective agar culture medium IVD
Cystine Lactose Electrolyte Deficient (CLED) Agar is used for the differentiation and enumeration of microorganisms in urine.
NEOGEN CORPORATION
2
In Commercial Distribution

  • 00860003684665 ()
NCM0034C

  • Differential/selective agar culture medium IVD
Cystine Lactose Electrolyte Deficient (CLED) Agar is used for the differentiation and enumeration of microorganisms in urine.
NEOGEN CORPORATION
2
In Commercial Distribution

  • 00860003684658 ()
NCM0034B

  • Differential/selective agar culture medium IVD
Cystine Lactose Electrolyte Deficient (CLED) Agar is used for the differentiation and enumeration of microorganisms in urine.
NEOGEN CORPORATION
2
In Commercial Distribution

  • 00860003684641 ()
NCM0034A

  • Differential/selective agar culture medium IVD
Nasal / Respiratory Specimen Collection Kit – 100 pack
KEYSTONE MANUFACTURING, LLC
KMSVKIT-KM03-100
In Commercial Distribution

  • 00860003793794 ()


  • General tissue specimen container IVD, fixative/saline
  • General-purpose absorbent tip applicator/swab, single-use
Nasal / Respiratory Specimen Collection Kit – 100 pack
KEYSTONE MANUFACTURING, LLC
KMSVKIT-KM01-100
In Commercial Distribution

  • 00860003793770 ()


  • General tissue specimen container IVD, fixative/saline
  • General-purpose absorbent tip applicator/swab, single-use
Cystine Lactose Electrolyte Deficient (CLED) Agar is used for the differentiation and enumeration of microorganisms in urine.
NEOGEN CORPORATION
0
In Commercial Distribution

  • 00860003684696 ()
NCM0256

  • Differential/selective agar culture medium IVD
Cystine Lactose Electrolyte Deficient (CLED) Agar is used for the differentiation and enumeration of microorganisms in urine.
NEOGEN CORPORATION
2
In Commercial Distribution

  • 00860003684672 ()
NCM0034D

  • Differential/selective agar culture medium IVD
A dip slide culture method for diagnosing urinary tract infections by demonstrating microbes in urine.
Aidian Oy
68197
In Commercial Distribution

  • 06438115000044 ()
  • 06438115001089 ()
68197

  • Multiple formulation agar culture medium IVD
A dip slide culture method for the detection of bacteriuria and the presumptive identification of uropathogens.
Aidian Oy
68014
In Commercial Distribution

  • 06438115000037 ()
  • 06438115001041 ()
1000

  • Multiple formulation agar culture medium IVD
A dip slide culture method for the detection of bacteriuria and the presumptive identification of uropathogens.
Aidian Oy
68019
In Commercial Distribution

  • 06438115000020 ()
  • 06438115001072 ()
1001

  • Multiple formulation agar culture medium IVD
A dip slide culture method for the detection of bacteriuria and the presumptive identification of uropathogens.
Aidian Oy
68018
In Commercial Distribution

  • 06438115000013 ()
  • 06438115001065 ()
1002

  • Multiple formulation agar culture medium IVD
A dip slide culture method for the detection of bacteriuria and the presumptive identification of uropathogens.
Aidian Oy
68017
In Commercial Distribution

  • 06438115000006 ()
  • 06438115001058 ()
1003

  • Multiple formulation agar culture medium IVD
selective agar plate for screening and aid to diagnosis by isolation of NTM colonies from sputum samples from cystic fibrosis patients and from respiratory specimens from non-cystic fibrosis patients
BIOMERIEUX SA
NTM Elite agar
In Commercial Distribution

  • 03573026609856 ()
  • 03573026609801 ()
  • 03573026608996 ()


  • Differential/selective agar culture medium IVD
Chromogenic medium for the selective isolation and differentiation of the genus Salmonella
BIOMERIEUX SA
chromID™ Salmonella Agar
Not in Commercial Distribution

  • 03573026118877 ()
  • 03573026600839 ()
  • 03573026600846 ()


  • Differential/selective agar culture medium IVD
Selective isolation and direct identification of Staphylococcus aureus
BIOMERIEUX SA
chromID™ S. aureus Elite agar (SAIDE)
In Commercial Distribution

  • 03573026494445 ()
  • 03573026600440 ()
  • 03573026600457 ()


  • Differential/selective agar culture medium IVD
Chromogenic medium for the detection and ident ification of Clostridium difficile.
BIOMERIEUX SA
chromID™ CDIF
In Commercial Distribution

  • 03573026316969 ()
  • 03573026600075 ()
  • 03573026600082 ()


  • Differential/selective agar culture medium IVD
Chromogenic medium for the selective isolation of yeasts and the direct identification of Candida albicans
BIOMERIEUX SA
chromID™ Candida Agar
In Commercial Distribution

  • 03573026118952 ()
  • 03573026599812 ()
  • 03573026599829 ()
  • 03573026118969 ()


  • Differential/selective agar culture medium IVD
Direct identification of Pseudomonas aeruginosa in pulmonary specimens.
BIOMERIEUX SA
chromID™ PAID
In Commercial Distribution

  • 03573026216801 ()
  • 03573026599416 ()
  • 03573026599423 ()


  • Differential/selective agar culture medium IVD
chromID™ Salmonella Eliteagar is a chromogenic medium for the selective isolation and identification of Salmonellain human specimens (stools)
BIOMERIEUX SA
chromID™ Salmonella Elite Agar
In Commercial Distribution

  • 03573026374846 ()
  • 03573026597313 ()
  • 03573026597320 ()


  • Differential/selective agar culture medium IVD
API 50 CHB/E Medium is for ID of Bacillus, related genera, and GN rods (Enterobacteriaceae and Vibrionaceae). It allows fermentation of 49 carbohydrates on API 50 CH strip
BIOMERIEUX SA
API® 50 CHB/E Medium
In Commercial Distribution

  • 03573026087494 ()
  • 03573026588724 ()


  • Multiple Enterobacteriaceae species culture isolate identification IVD, reagent
API 50 CHL Medium, for ID of Lactobacillus and related genera, is a ready-to-use allowing fermentation of the 49 carbohydrates on the API 50 CH strip (Ref. 50 300).
BIOMERIEUX SA
API® 50 CHL Medium
In Commercial Distribution

  • 03573026087456 ()
  • 03573026588717 ()


  • Multiple aerobic gram positive bacteria species culture isolate identification IVD, reagent
API 50 CH combines 50 biochemical tests for ID of Lactobacillus and related genera as well as Bacillus and related genera, Enterobacteriaceae and Vibrionaceae.
BIOMERIEUX SA
API® 50 CH
In Commercial Distribution

  • 03573026087401 ()
  • 03573026588694 ()


  • Multiple bacteria species culture isolate identification control IVD, kit
API M Medium allows the differentiation between motile and non-motile bacteria of the facultative aero-anaerobic group. It can be used to complement the API 20 E strip.
BIOMERIEUX SA
API® M Medium
In Commercial Distribution

  • 03573026087364 ()
  • 03573026588687 ()


  • Multiple Enterobacteriaceae species culture isolate identification IVD, reagent
Trypcase Soy broth is a culture medium for the growth of most non-fastidious micro-organisms (bacteria and fungi)
BIOMERIEUX SA
42100
In Commercial Distribution

  • 03573026073589 ()
  • 03573026598426 ()


  • Basic/simple nutrient broth culture medium IVD
BD BBL™ Columbia CNA w/5 % SB / Columbia CNA w/5 % SB
BECTON, DICKINSON AND COMPANY
299818
In Commercial Distribution

  • 10382902998188 ()
  • 00382902998181 ()
  • 30382902998182 ()

  • Outer Diameter: 100 Millimeter
  • Depth: 15 Millimeter
299818

  • Differential/selective agar culture medium IVD
BD BBL™ MacConkey II Agar with Sorbitol, Ctn. of 100 plates
BECTON, DICKINSON AND COMPANY
298519
In Commercial Distribution

  • 10382902985195 ()
  • 00382902985198 ()
  • 30382902985199 ()
  • 60382902985190 ()

  • Depth: 15 Millimeter
  • Outer Diameter: 100 Millimeter
298519

  • Differential/selective agar culture medium IVD
BD BBL™ Inhibitory Mold Agar Deep Fill
BECTON, DICKINSON AND COMPANY
298191
In Commercial Distribution

  • 30382902981917 ()
  • 10382902981913 ()
  • 60382902981918 ()
  • 00382902981916 ()
298191

  • Differential/selective agar culture medium IVD
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