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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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InTray® DM - B08820630

An enriched dermatophyte medium used in the detection of dermatophytes from clinical specimens.
BIO-MED DIAGNOSTICS, INC.
2063
In Commercial Distribution

  • B08820630 ()
  • B08820634 ()
  • B08820632 ()
22-063-000

  • Multiple dermatophyte species culture isolate identification IVD, kit

Saline Solution (0.85%) - B08816120

Saline Solution (0.85%) is a saline solution for viral specimens.
BIO-MED DIAGNOSTICS, INC.
1612
In Commercial Distribution

  • B08816120 ()
  • B08816121 ()
  • B08816122 ()
11-612-001

  • Saline suspension medium/diluent IVD

InTray DM-FungID - B08815930

InTray® DM-FungID™ is an enriched dermatophyte medium used to aid in the detection of dermatophytes from clinical specimens with mixed micobiota.
BIO-MED DIAGNOSTICS, INC.
1593
In Commercial Distribution

  • B08815934 ()
  • B08815930 ()
  • B08815932 ()
21-593-001

  • Multiple dermatophyte species culture isolate identification IVD, kit

InTray® BHI - B08815030

Agar is a general purpose nutrient medium recommended for the cultivation and isolation of a variety of microorganisms, including bacteria, yeasts, and molds.
BIO-MED DIAGNOSTICS, INC.
1503
In Commercial Distribution

  • B08815034 ()
  • B08815030 ()
  • B08815032 ()
21-503-001

  • Basic/simple nutrient agar culture medium IVD

InTray® XLT4 - B08814930

A medium devised for selection of non-typhi Salmonella from samples contaminated with fecal matter. Growth of other organisms is inhibited and Salmonella can be differentiated from other organisms by colony color.
BIO-MED DIAGNOSTICS, INC.
1493
In Commercial Distribution

  • B08814934 ()
  • B08814930 ()
  • B08814932 ()
21-493-001

  • Salmonella/Shigella species agar culture medium IVD

InTray® SMA - B08814230

a selective and differential media for the detection of sorbitol-non-fermenting Escherichia coli serotype O157:H7 associated with hemorrhagic colitis. This medium is also referred to as "MacConkey Sorbitol Agar."
BIO-MED DIAGNOSTICS, INC.
1423
In Commercial Distribution

  • B08814234 ()
  • B08814230 ()
  • B08814232 ()
21-423-001

  • Sorbitol-MacConkey E. coli agar culture medium IVD

InTray® PDA - B08812930

Recommended by the American Public Health Association for plate counts of yeasts and molds in the examination of foods and dairy products, it is also used for maintenance, cultivation and sporulation of stock cultures of various dermatophytes and for differentiation of atypical varieties of dermatophytes by pigment production.
BIO-MED DIAGNOSTICS, INC.
1293
In Commercial Distribution

  • B08812934 ()
  • B08812930 ()
  • B08812932 ()
21-293-001

  • Potato-dextrose fungal agar culture medium IVD

InTray® SAB - B08812630

A general-purpose medium for the cultivation of pathogenic and non-pathogenic fungi, including dermatophytes. The low pH (approximately 5.6) is favorable for growth of fungi, especially yeasts and dermatophytes. Sabouraud's Dextrose Agar (SAB) is slightly inhibitory to contaminating bacteria in clinical specimens.
BIO-MED DIAGNOSTICS, INC.
1263
In Commercial Distribution

  • B08812634 ()
  • B08812630 ()
  • B08812632 ()
21-263-001

  • Basic/simple nutrient agar culture medium IVD

InPouch® TVC Subculture - B08810510

A highly selective growth medium which maintains viable Trichomonas vaginalis cultures (positive controls) for up to seven (7) days.
BIO-MED DIAGNOSTICS, INC.
1051
In Commercial Distribution

  • B08810510 ()
  • B08810513 ()
21-051-001

  • Differential/selective broth culture medium IVD

EDGE BIOLOGICALS INC - B645T0800

LIM BROTH 5ML
EDGE BIOLOGICALS, INC.
T0800
Not in Commercial Distribution

  • B645T08001 ()
  • B645T0800 ()


  • Differential/selective broth culture medium IVD

EDGE BIOLOGICALS INC - B645T0775

UREA BROTH 2ML
EDGE BIOLOGICALS, INC.
T0775
Not in Commercial Distribution

  • B645T07751 ()
  • B645T0775 ()


  • Differential/selective broth culture medium IVD

EDGE BIOLOGICALS INC - B645T0772

UREA BROTH 5ML
EDGE BIOLOGICALS, INC.
T0772
Not in Commercial Distribution

  • B645T07721 ()
  • B645T0772 ()


  • Differential/selective broth culture medium IVD

EDGE BIOLOGICALS INC - B645T0771

UREA AGAR SLANTS
EDGE BIOLOGICALS, INC.
T0771
Not in Commercial Distribution

  • B645T07711 ()
  • B645T0771 ()


  • Differential/selective agar culture medium IVD

EDGE BIOLOGICALS INC - B645T0765

TRYPTIC SOY BROTH W/ 20% GLYCEROL 5ML
EDGE BIOLOGICALS, INC.
T0765
Not in Commercial Distribution

  • B645T07651 ()
  • B645T0765 ()


  • Basic/simple nutrient broth culture medium IVD

EDGE BIOLOGICALS INC - B645T0764

TRYPTIC SOY BROTH W/ 15% GLYCEROL 2ML
EDGE BIOLOGICALS, INC.
T0764
Not in Commercial Distribution

  • B645T07641 ()
  • B645T0764 ()


  • Basic/simple nutrient broth culture medium IVD

EDGE BIOLOGICALS INC - B645T0762

TRYPTIC SOY BROTH W/ 6.5% NACL 5ML
EDGE BIOLOGICALS, INC.
T0762
Not in Commercial Distribution

  • B645T07621 ()
  • B645T0762 ()


  • Differential/selective broth culture medium IVD

EDGE BIOLOGICALS INC - B645T0759

TRYPTIC SOY AGAR SLANT
EDGE BIOLOGICALS, INC.
T0759
Not in Commercial Distribution

  • B645T07591 ()
  • B645T0759 ()


  • Basic/simple nutrient agar culture medium IVD

EDGE BIOLOGICALS INC - B645T0757

TRYPTIC SOY BROTH 5ML
EDGE BIOLOGICALS, INC.
T0757
Not in Commercial Distribution

  • B645T07571 ()
  • B645T0757 ()


  • Basic/simple nutrient broth culture medium IVD

EDGE BIOLOGICALS INC - B645T0756

TRYPTIC SOY BROTH 4.5ML
EDGE BIOLOGICALS, INC.
T0756
Not in Commercial Distribution

  • B645T07561 ()
  • B645T0756 ()


  • Basic/simple nutrient broth culture medium IVD

EDGE BIOLOGICALS INC - B645T0755

TRYPTIC SOY BROTH 2ML
EDGE BIOLOGICALS, INC.
T0755
Not in Commercial Distribution

  • B645T07551 ()
  • B645T0755 ()


  • Basic/simple nutrient broth culture medium IVD

EDGE BIOLOGICALS INC - B645T0749

TRYPTIC SOY AGAR 20ML DEEP
EDGE BIOLOGICALS, INC.
T0749
Not in Commercial Distribution

  • B645T07491 ()
  • B645T0749 ()


  • Basic/simple nutrient agar culture medium IVD

EDGE BIOLOGICALS INC - B645T0722

THIOGLYCOLLATE BROTH W/ IND 5ML
EDGE BIOLOGICALS, INC.
T0722
Not in Commercial Distribution

  • B645T07221 ()
  • B645T0722 ()


  • Differential/selective broth culture medium IVD

EDGE BIOLOGICALS INC - B645T0721

THIOGLYCOLLATE BROTH THIOGLYCOLLATE BROTH W/O INDICATOR 5ML
EDGE BIOLOGICALS, INC.
T0721
In Commercial Distribution

  • B645T0721 ()


  • Basic/simple nutrient broth culture medium IVD

EDGE BIOLOGICALS INC - B645T0718

THIOGLYCOLLATE BROTH W/ IND 10ML
EDGE BIOLOGICALS, INC.
T0718
Not in Commercial Distribution

  • B645T07181 ()
  • B645T0718 ()


  • Differential/selective broth culture medium IVD

EDGE BIOLOGICALS INC - B645T0714

THIOGLYCOLLATE BROTH W/O IND 10ML
EDGE BIOLOGICALS, INC.
T0714
Not in Commercial Distribution

  • B645T07141 ()
  • B645T0714 ()


  • Differential/selective broth culture medium IVD

EDGE BIOLOGICALS INC - B645T0713

THIOGLYCOLLATE BROTH W/ IND 9ML
EDGE BIOLOGICALS, INC.
T0713
Not in Commercial Distribution

  • B645T07131 ()
  • B645T0713 ()


  • Differential/selective broth culture medium IVD

EDGE BIOLOGICALS INC - B645T0711

THIOGLYCOLLATE BROTH W/O IND 7ML
EDGE BIOLOGICALS, INC.
T0711
Not in Commercial Distribution

  • B645T07111 ()
  • B645T0711 ()


  • Differential/selective broth culture medium IVD

EDGE BIOLOGICALS INC - B645T0637

SALINE 0.85% 9ML
EDGE BIOLOGICALS, INC.
T0637
Not in Commercial Distribution

  • B645T06371 ()
  • B645T0637 ()


  • Saline suspension medium/diluent IVD

EDGE BIOLOGICALS INC - B645T0626

SALINE 0.85% 9.9ML
EDGE BIOLOGICALS, INC.
T0626
Not in Commercial Distribution

  • B645T06261 ()
  • B645T0626 ()


  • Saline suspension medium/diluent IVD

EDGE BIOLOGICALS INC - B645T0616

SALINE 0.85% 5ML
EDGE BIOLOGICALS, INC.
T0616
Not in Commercial Distribution

  • B645T06161 ()
  • B645T0616 ()


  • Saline suspension medium/diluent IVD

EDGE BIOLOGICALS INC - B645T0611

SALINE 0.85% 5ML
EDGE BIOLOGICALS, INC.
T0611
Not in Commercial Distribution

  • B645T06111 ()
  • B645T0611 ()


  • Saline suspension medium/diluent IVD

EDGE BIOLOGICALS INC - B645T0604

SALINE 0.85% 2ML
EDGE BIOLOGICALS, INC.
T0604
Not in Commercial Distribution

  • B645T06041 ()
  • B645T0604 ()


  • Saline suspension medium/diluent IVD

EDGE BIOLOGICALS INC - B645T0603

SALINE 0.85% 1ML
EDGE BIOLOGICALS, INC.
T0603
Not in Commercial Distribution

  • B645T06031 ()
  • B645T0603 ()


  • Saline suspension medium/diluent IVD

EDGE BIOLOGICALS INC - B645T0601

SALINE 0.45% 3ML
EDGE BIOLOGICALS, INC.
T0601
Not in Commercial Distribution

  • B645T06011 ()
  • B645T0601 ()


  • Saline suspension medium/diluent IVD

EDGE BIOLOGICALS INC - B645T0577

SABOURAUD DEXTROSE AGAR SLANTS
EDGE BIOLOGICALS, INC.
T0577
Not in Commercial Distribution

  • B645T05771 ()
  • B645T0577 ()


  • Differential/selective agar culture medium IVD

EDGE BIOLOGICALS INC - B645T0496

PHENYLALANINE AGAR SLANTS
EDGE BIOLOGICALS, INC.
T0496
Not in Commercial Distribution

  • B645T04961 ()
  • B645T0496 ()


  • Differential/selective agar culture medium IVD

EDGE BIOLOGICALS INC - B645T0160

Campy Thioglycolate Broth
EDGE BIOLOGICALS, INC.
T0160
Not in Commercial Distribution

  • B645T0160 ()
  • B645T01601 ()


  • Enriched broth culture medium IVD

EDGE BIOLOGICALS INC - B645T0120

Chocolate Agar Slant
EDGE BIOLOGICALS, INC.
T0120
Not in Commercial Distribution

  • B645T0120 ()
  • B645T01201 ()


  • Enriched agar culture medium IVD

EDGE BIOLOGICALS INC - B645T0110

SALINE 0.85% 1ML, FILTERED
EDGE BIOLOGICALS, INC.
T0110
Not in Commercial Distribution

  • B645T01101 ()
  • B645T0110 ()


  • Saline suspension medium/diluent IVD

EDGE BIOLOGICALS INC - B645T0096

BLOOD AGAR SLANT
EDGE BIOLOGICALS, INC.
T0096
Not in Commercial Distribution

  • B645T00961 ()
  • B645T0096 ()


  • Enriched agar culture medium IVD
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