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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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Family Wellness - 00032251057663

Early Result Pregnancy Test 1CT
FOURSTAR GROUP INC.
0939504
In Commercial Distribution

  • 00032251057663 ()


  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid

Family Wellness - 00032251056192

Early Result Pregnancy Test 2CT
FOURSTAR GROUP INC.
0903756
In Commercial Distribution

  • 00032251056192 ()


  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid

OSOM Ultra hCG 25T Kit - 00742860100208

OSOM Ultra hCG 25T Kit
SEKISUI DIAGNOSTICS, LLC
1004
In Commercial Distribution

  • 00742860100208 ()
  • 10742860100205 ()
1004

  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid

OSOM hCG Urine 10 Test Kit - 00742860100154

No Description
SEKISUI DIAGNOSTICS, LLC
101-10
In Commercial Distribution

  • 00742860100154 ()
  • 10742860100151 ()
101-10

  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid

OSOM hCG Card 5 Test kit - 00742860100079

No Description
SEKISUI DIAGNOSTICS, LLC
102W-5
In Commercial Distribution

  • 00742860100079 ()
  • 10742860100076 ()
102W-5

  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid

HCG COMBO, MERIDIAN 25 test Kit - 00742860100031

No Description
SEKISUI DIAGNOSTICS, LLC
755425
In Commercial Distribution

  • 00742860100031 ()
  • 10742860100038 ()
755425

  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid

OSOM Combo hCG 25 Test kit - 00742860001246

No Description
SEKISUI DIAGNOSTICS, LLC
124
In Commercial Distribution

  • 00742860001246 ()
  • 10742860001243 ()
124

  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid

OSOM hCG Card 25 Test Kit - 00742860001024

No Description
SEKISUI DIAGNOSTICS, LLC
102W
In Commercial Distribution

  • 00742860001024 ()
  • 10742860001021 ()
102W

  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid

OSOM hCG Urine 50 Test Kit - 00742860001017

No Description
SEKISUI DIAGNOSTICS, LLC
101
In Commercial Distribution

  • 00742860001017 ()
  • 10742860001014 ()
101

  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid

Complete Circle Health - 00860383000307

Home Midstream Pregnancy Test
PWL SOLUTIONS LLC
LMBCS20A99
Not in Commercial Distribution

  • 00860383000307 ()
  • 00860383000314 ()

  • Width: 6.0 Millimeter


  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid
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