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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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Toxi-Titer Plate, 48 Wells
MARDX DIAGNOSTICS, INC.
B1029-70D
In Commercial Distribution

  • 05391516747998 ()
B1029-70D

  • Clostridium difficile toxin A/B antigen IVD, reagent
Bartels® Cytotoxicity Assay for Clostridium difficile Toxin Product B1029-70, Store Toxi-Titer Plate @ 35-37 °C, Store Reagents @ 2-8 °C, 48 Tests
MARDX DIAGNOSTICS, INC.
B1029-70
In Commercial Distribution

  • 05391516747950 ()
B1029-70

  • Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)
ACCURUN 345 Series 150 HIV-1 RNA, HCV RNA, HBV DNA 5 x 4.0 mL
Lgc Clinical Diagnostics, Inc.
2020-0105
In Commercial Distribution

  • 00816784020628 ()

  • Total Volume: 20 Milliliter
2020-0105

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control
ACCURUN 345 Series 150 HIV-1 RNA, HCV RNA, HBV DNA 5 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2020-0104
In Commercial Distribution

  • 00816784020611 ()

  • Total Volume: 5 Milliliter
2020-0104

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control
96 Test enzyme immunoassay kit for the determination of FIX Antigen
Affinity Biologicals Inc
FIX-AG
In Commercial Distribution



  • Coagulation factor IX IVD, kit, enzyme immunoassay (EIA)
VIDAS ® C. difficile GDH is is a qualitative test for use on VIDAS family instruments to detect C. difficile antigen
BIOMERIEUX SA
30125-01
In Commercial Distribution

  • 03573026444204 ()


  • Clostridium difficile antigen IVD, antibody
The VIDAS ® C. difficile Toxin A & B is a test for use on VIDAS family instruments for the qualitative detection of Clostridium difficile toxin A and B in stool specimens
BIOMERIEUX SA
30118-01
In Commercial Distribution

  • 03573026229146 ()


  • Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)
Amplichek I MiniPak (An assayed nucleic acid control.)
BIO-RAD LABORATORIES, INC.
12000531
In Commercial Distribution

  • 03610520530092 ()
12000531

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control
Amplichek I Level 3 (An assayed nucleic acid control.)
BIO-RAD LABORATORIES, INC.
12000530
In Commercial Distribution

  • 03610520530085 ()
12000530

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control
Amplichek I Level 2 (An assayed nucleic acid control.)
BIO-RAD LABORATORIES, INC.
12000529
In Commercial Distribution

  • 03610520530078 ()
12000529

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control
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