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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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For isolation and differentiation of major clinically significant Candida species. Suitable for direct streaking of samples from skin,sputum, urine or genitourinary swabs.
BIO-MED DIAGNOSTICS, INC.
1113
In Commercial Distribution

  • B08811134 ()
  • B08811130 ()
  • B08811132 ()
21-113-001

  • Multiple Candida/yeast species culture isolate identification IVD, kit
For rapid isolation and differentiation of urinary tract pathogens. Suitable for direct plating of urine specimens.
BIO-MED DIAGNOSTICS, INC.
1103
In Commercial Distribution

  • B08811034 ()
  • B08811030 ()
  • B08811032 ()
21-103-001

  • Multiple urinary tract pathogen culture isolate identification IVD, kit, rapid
Self-contained media system for the recovery and detection of T. vaginalis from female vaginal samples or male urethra/urine samples.
BIO-MED DIAGNOSTICS, INC.
1031
In Commercial Distribution

  • B08810310 ()
  • B08810317 ()
  • B08810313 ()
21-031-001

  • Differential/selective broth culture medium IVD
Cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage embryos
BIOTECH INCORPORATED
CL-R-CT
Not in Commercial Distribution

  • B056CLRCT2 ()
  • B056CLRCT1 ()
  • B056CLRCT0 ()
  • B056CLRCT5 ()
CL-R-CT

  • Assisted reproduction vitrification carrier
CryoPRO™-5 Cryopreservation/Storage Bag Set
Thermogenesis Corp.
SGI-0442
In Commercial Distribution

  • B039SGI04421 ()
  • B039SGI04420 ()
  • B039SGI04429 ()


  • Blood cell freeze/thaw system
SynGenX®-1000 Disposable Cartridge
Thermogenesis Corp.
SGI-0305
In Commercial Distribution

  • B039SGI03050 ()
  • B039SGI03051 ()
  • B039SGI03059 ()


  • Umbilical cord blood collection set
CryoPRO™-2 Cryopreservation/Storage Bag Set
Thermogenesis Corp.
SGI-0091
In Commercial Distribution

  • B039SGI00911 ()
  • B039SGI00910 ()
  • B039SGI00919 ()


  • Blood cell freeze/thaw system
SUTURE,PDO,0,NFSL
American Health Service Sales Corporation
MV-Z587
In Commercial Distribution

  • B031MVZ5870 ()
  • B031MVZ5871 ()
  • B031MVZ5872 ()


  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial
SUTURE,PDO,1,NCP-1
American Health Service Sales Corporation
MV-Z468
In Commercial Distribution

  • B031MVZ4680 ()
  • B031MVZ4681 ()
  • B031MVZ4682 ()


  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial
SUTURE,PDO,0,NCP-1
American Health Service Sales Corporation
MV-Z467
In Commercial Distribution

  • B031MVZ4670 ()
  • B031MVZ4671 ()
  • B031MVZ4672 ()


  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial
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