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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ACCUTRON, INC.
34070-CUSTOM
Not in Commercial Distribution

  • 90813830020048 ()
34070-CUSTOM

  • Nitrous oxide quick-connect coupling, male
Kit Contains: CA090, DIRECT DRIVE® LCA 3/BX CB030, 5mmx35cm EPIX® LAPA SCISSOR, 10/BX C6001, 5mmX33cm PROB/VALV DUAL BAG 12/BX C0R85, 12x100MM Kii® BLT TIP SYS 6/BX CTF12, 5x100 Kii® Fios® ZTHR DP 10/BX CTF33, 11x100 Kii® Fios® ZTHR 6/BX
APPLIED MEDICAL RESOURCES CORPORATION
K0592
In Commercial Distribution

  • 30607915120499 ()


  • Laparoscopic access cannula, single-use
  • Laparoscopic irrigation/aspiration cannula
  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
  • Ligation clip, metallic
Sub Q infusion set. Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.
Unomedical A/S
71-060-2738
Not in Commercial Distribution

  • 05705244004672 ()
  • 05705244009868 ()
  • 05705244004689 ()

  • Length: 60 Centimeter
  • Depth: 8 Millimeter
  • Angle: 90 degree


  • Electric infusion pump administration set, single-use
The ZEUS ELISA Helicobacter pylori IgG Test System is an enzyme-linked immunosorbent assay for the qualitative detection of IgG antibodies to H. pylori in sera from symptomatic adults. This device is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
Q3Z51021GB
In Commercial Distribution

  • 00845533000642 ()
Q3Z51021GB

  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The ZEUS ANA HEp-2 Test System is a prestandardized kit designed for the qualitative and semi-quantitative detection of antinuclear antibodies. The test is intended to aid in determining SLE and differentiating clinically similar connective tissue disorders, and is for in vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
Q240961
In Commercial Distribution

  • 00845533001700 ()
Q240961

  • Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, fluorescent immunoassay
The ZEUS ANA HEp-2 Test System is a prestandardized kit designed for the qualitative and semi-quantitative detection of antinuclear antibodies. The test is intended to aid in determining SLE and differentiating clinically similar connective tissue disorders, and is for in vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
Q240241
In Commercial Distribution

  • 00845533001694 ()
Q240241

  • Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, fluorescent immunoassay
The ZEUS ANA HEp-2 Test System is a prestandardized kit designed for the qualitative and semi-quantitative detection of antinuclear antibodies. The test is intended to aid in determining SLE and differentiating clinically similar connective tissue disorders, and is for in vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
Q240181
In Commercial Distribution

  • 00845533001687 ()
Q240181

  • Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, fluorescent immunoassay
The ZEUS ELISA Toxoplasma gondii IgG Test System is designed for the qualitative and/or quantitative determination of IgG antibodies to Toxoplasma gondii in human serum. The assay is intended to be used to evaluate serologic evidence of previous infection with T. gondii, and is for In Vitro diagnostic use. This product is not FDA cleared (approved) for use in screening blood or plasma donors.
ZEUS SCIENTIFIC, INC.
Q8Z8651GB
In Commercial Distribution

  • 00845533001205 ()
Q8Z8651GB

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The ZEUS ELISA Mycoplasma pneumoniae IgG Test System provides a means for the qualitative detection of IgG antibodies to Mycoplasma pneumoniae in human sera. The test may aid in the determination of the patient’s serological status, or may aid in the diagnosis of disease associated with Mycoplasma pneumoniae. Potential cross-reactivity with M. genitalium has not been assessed, nor were studies performed on very young and/or elderly patients.
ZEUS SCIENTIFIC, INC.
Q3Z17601GB
In Commercial Distribution

  • 00845533000918 ()
Q3Z17601GB

  • Mycoplasma pneumoniae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Rabbit antisera. Ready-To-Use.
Ssi Diagnostica A/S
53827
Not in Commercial Distribution

  • 05713106538272 ()
53827

  • Multiple Salmonella species culture isolate antigen IVD, antibody
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