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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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EUROIMMUN Medizinische Labordiagnostika AG
DL 1300-1601-8 G
In Commercial Distribution

  • 04049016124887 ()


  • Multiple liver disease-associated antibody IVD, kit, enzyme immunoassay (EIA)
1. 1x PBC Screen IgG/IgA ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted PBC Screen IgG/IgA ELISA Low Positive 4. 1x 1.2mL prediluted PBC Screen IgG/IgA ELISA High Positive 5. 1x 50mL HRP Sample Diluent 6. 1x 25mL HRP Wash Concentrate, 40x concentrate 7. 1x 10mL HRP PBC Screen IgG/IgA Conjugate, (goat), anti-human IgG/IgA 8. 1x 10mL TMB Chromogen 9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid
INOVA DIAGNOSTICS, INC.
704560
In Commercial Distribution

  • 08426950594239 ()


  • Multiple liver disease-associated antibody IVD, kit, enzyme immunoassay (EIA)
ABBOTT PRISM Positive Run Control Kit
ABBOTT LABORATORIES
3E60-11
Not in Commercial Distribution

  • 00380740039219 ()
03E6011

  • Multiple blood-borne virus antigen/antibody IVD, control
ABBOTT PRISM Run Control Kit
ABBOTT LABORATORIES
3E60-10
Not in Commercial Distribution

  • 00380740038403 ()
03E6010

  • Multiple blood-borne virus antigen/antibody IVD, control
Xpect C. diff Toxin A/B KT/20TST
REMEL, INC.
R24650
In Commercial Distribution

  • 30848838027094 ()
  • 00848838027093 ()


  • Clostridium difficile antigen IVD, kit, rapid ICT, clinical
Xpect C. diff Toxin A/B KT/40TST
REMEL, INC.
R24640
In Commercial Distribution

  • 30848838068417 ()
  • 00848838068416 ()


  • Clostridium difficile antigen IVD, kit, rapid ICT, clinical
VIROTROL I (An unassayed (human) serological control.)
BIO-RAD LABORATORIES, INC.
00102C
In Commercial Distribution

  • 00847661005780 ()
00102C

  • Multiple blood-borne virus antigen/antibody IVD, control
VIROTROL I (An unassayed (human) serological control.)
BIO-RAD LABORATORIES, INC.
00102B
In Commercial Distribution

  • 00847661005773 ()
00102B

  • Multiple blood-borne virus antigen/antibody IVD, control
VIROTROL II (An unassayed (human) serological control.)
BIO-RAD LABORATORIES, INC.
00115B
In Commercial Distribution

  • 00847661005629 ()
00115B

  • Multiple blood-borne virus antigen/antibody IVD, control
VIROTROL I (An unassayed (human) serological control.)
BIO-RAD LABORATORIES, INC.
00101G
In Commercial Distribution

  • 00847661005551 ()
00101G

  • Multiple blood-borne virus antigen/antibody IVD, control
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