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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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A chromogenic medium for selective isolation and differentiation of Salmonella species, (e.g., Enterobacteriaceae and other enteric bacteria).The test can be performed with samples composed of mixed populations of bacteria, e.g stool, blood, biological fluids, surface streaks, etc. High sensitivity and specificity of the medium lead to a higher detection rate of Salmonella spp. Selective agents inhibit the growth of gram-positive organisms. Artificial substrates are metabolized by specific microbial enzymes liberating insoluble chromogenic compounds. Salmonella species produce deep pink to mauve colored colonies. Bacteria other than Salmonella spp. produce blue colonies, or are colorless or inhibited.
BIO-MED DIAGNOSTICS, INC.
1223
In Commercial Distribution

  • B08812234 ()
  • B08812230 ()
  • B08812232 ()
21-223-001

  • Chromogenic Salmonella species agar culture medium IVD
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
1AX Wearable Biosensor
Lifesignals, Inc.
UB1550
In Commercial Distribution

  • B353UB15501 ()
  • B353UB15502 ()
  • B353UB15503 ()


  • Wearable multiple physiological parameter recorder, reusable
Wearable Biosensor - ECG Remote Monitoring Biosensor Patch
Lifesignals, Inc.
MM1250
Not in Commercial Distribution

  • B353MM12501 ()
  • B353MM12502 ()
  • B353MM12503 ()


  • Electrocardiography telemetric monitoring system
Wearable Biosensor - ECG Remote Monitoring Biosensor Patch
Lifesignals, Inc.
MA1251
Not in Commercial Distribution

  • B353MA12512 ()
  • B353MA12511 ()
  • B353MA12513 ()
MA1251_US

  • Electrocardiography telemetric monitoring system
Wearable Biosensor - ECG Remote Monitoring Biosensor Patch
Lifesignals, Inc.
LP1253
In Commercial Distribution

  • B353LP12532 ()
  • B353LP12531 ()
  • B353LP12533 ()
LP1253_US

  • Electrocardiography telemetric monitoring system
Wearable Biosensor - ECG Remote Monitoring Biosensor Patch
Lifesignals, Inc.
LP1250
Not in Commercial Distribution

  • B353LP12502 ()
  • B353LP12501 ()
  • B353LP12503 ()


  • Electrocardiographic ambulatory recorder
Biosensor Patch - Electrocardiography Telemetric Monitoring Patch
Lifesignals, Inc.
LP1110
Not in Commercial Distribution

  • B353LP11103 ()
  • B353LP11102 ()
  • B353LP11101 ()


  • Electrocardiography telemetric monitoring system
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