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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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MARTIN LEWIS AGAR
Healthlink
1095
In Commercial Distribution

  • M20210952 ()
  • M20210951 ()
  • M20210950 ()

  • Outer Diameter: 100 Millimeter
  • 100 mm
1095

  • Neiserria species agar culture medium IVD, basic
The Serim PyloriTek Test Kit detects urease activity in gastric biopsy specimens for the presumptive identification of Helicobacter pylori.
SERIM RESEARCH CORPORATION
05140S
In Commercial Distribution

  • M1745140S2 ()
  • M1745140S1 ()
  • M1745140S0 ()
05140S

  • Helicobacter pylori urease IVD, kit, chromogenic
Serim DISINTEK GTA 1.5% Test Strips are used to determine whether the glutaraldehyde concentration is above or at/below the Minimum Effective Concentration (MEC) of 1.5% for CIDEX® or MetriCide® reusable glutaraldehyde high-level disinfectants.
SERIM RESEARCH CORPORATION
5136A
In Commercial Distribution

  • M1745136A1 ()
  • M1745136A0 ()
  • M1745136A2 ()
5136A

  • Glutaraldehyde device disinfectant/sterilant test strip
Serim® DISINTEK™ OPA Test Strips are chemical indicators for use in determining whether the concentration of ortho-phthalaldehyde, the active ingredient in CIDEX® OPA Solution and MetriCide® OPA Plus™ Solution, is above or below the established minimum effective concentration (MEC) of 0.3%.
SERIM RESEARCH CORPORATION
5121
In Commercial Distribution

  • M17451212 ()
  • M17451211 ()
  • M17451210 ()
5121

  • Ortho-phthalaldehyde (OPA) device disinfectant test strip
Serim® GUARDIAN™ BICARB pH II Test Strips are designed to test bicarbonate concentrate and/or final dialysate solutions for the appropriate pH where bicarbonate and acid and water are mixed in closed systems.
SERIM RESEARCH CORPORATION
5116B
Not in Commercial Distribution

  • M1745116B2 ()
  • M1745116B1 ()
  • M1745116B0 ()
5116B

  • Multi-parameter device tester
Serim® GUARDIAN™ Bicarb pH II Test Strips are designed to test bicarbonate concentrate and/or final dialysate solutions for the appropriate pH where bicarbonate and acid and water are mixed in closed systems.
SERIM RESEARCH CORPORATION
5116A
In Commercial Distribution

  • M1745116A1 ()
  • M1745116A2 ()
  • M1745116A0 ()
5116A

  • Multi-parameter device tester
The Serim® GUARDIAN™ HiSENSE™ Test Kit indicates low levels of total chlorine (chloramine and/or free chlorine) in water used to prepare dialysate.
SERIM RESEARCH CORPORATION
5109
In Commercial Distribution

  • M17451092 ()
  • M17451091 ()
  • M17451090 ()
5109

  • Multi-parameter device tester
SERIM® GUARDIAN™ Peracetic Acid Test Strips indicate the concentration (potency) of peracetic acid in dialyzer reprocessing concentrates such as Renalin® Cold Sterilant, PerAldecide™, Puristeril® 340, Peracidin™ and Micro-X®.
SERIM RESEARCH CORPORATION
5106
In Commercial Distribution

  • M17451061 ()
  • M17451060 ()
  • M17451062 ()
5106

  • Medical device disinfection solution test strip
Serim® GUARDIAN™ Residual Peroxide Test Strips measure the concentration of peroxide remaining in dialysate lines and dialyzers after disinfection with peracetic acid/peroxide-based disinfectants.
SERIM RESEARCH CORPORATION
5105
In Commercial Distribution

  • M17451052 ()
  • M17451051 ()
  • M17451050 ()
5105

  • Multi-parameter device tester
Serim® GUARDIAN™ Residual Chlorine Test Strips indicating the concentration of chlorine bleach (sodium hypochlorite) remaining in the solution used to rinse dialysate lines following disinfection of hemodialysis equipment.
SERIM RESEARCH CORPORATION
5100C
In Commercial Distribution

  • M1745100C2 ()
  • M1745100C1 ()
  • M1745100C0 ()
5100C

  • Multi-parameter device tester
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