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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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Urinalysis control designed specifically for the Iris Diagnostics iQ® automated urine analyzers. Contains 1 vial each of Level 1 & 2.
STRECK, INC.
213396
In Commercial Distribution

  • 00844509001966 ()

  • Total Volume: 120 Milliliter
213396

  • Urine sediment IVD, control
MDx-Chex™ for BC-GP is intended for use as an external positive and negative assayed control to monitor the performance of the qualitative detection of Gram-positive bacteria and associated antimicrobial resistance genes, by the Luminex VERIGENE® Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) on Luminex VERIGENE® systems. The MDx-Chex™ for BC-GP Positive and Negative Controls are composed of a buffered solution with stabilized erythrocytes and leukocytes in a matrix of blood culture media components. Positive Control: Gram-positive bacteria: Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, Enterococcus faecalis, Enterococcus faecium, Streptococcus anginosus group; Species: Staphylococcus spp., Streptococcus spp., Listeria spp.; antimicrobial resistance genes: mecA, vanA and vanB. Negative Control: buffered solution only. This product is not intended to replace manufacturer controls provided with the device.
STRECK, INC.
250079
In Commercial Distribution

  • 00844509002468 ()
250079

  • Multiple-type bloodstream pathogen nucleic acid IVD, control
Assayed linearity control kits that are used to determine the patient reportable range of 3-part and 5-part hematology instruments. Contains 1 vial each of PLT L1-6.
STRECK, INC.
291720
In Commercial Distribution

  • 00844509001591 ()

  • Total Volume: 3.0 Milliliter
291720

  • Full blood count IVD, control
Assayed linearity control kits that are used to determine the patient reportable range of 3-part and 5-part hematology instruments. Contains 1 vial each of WBC L1-5.
STRECK, INC.
291719
In Commercial Distribution

  • 00844509001584 ()

  • Total Volume: 3.0 Milliliter
291719

  • Full blood count IVD, control
Assayed linearity control kits that are used to determine the patient reportable range of 3-part and 5-part hematology instruments. Contains 1 vial each of RBC L1-5, WBC L1-5, PLT L1-6.
STRECK, INC.
291718
In Commercial Distribution

  • 00844509001577 ()

  • Total Volume: 3.0 Milliliter
291718

  • Full blood count IVD, control
Assayed linearity control kits that are used to determine the patient reportable range of 3-part and 5-part hematology instruments. Contains 1 vial each of RBC L1-4, WBC L1-4, PLT L1-4.
STRECK, INC.
291715
In Commercial Distribution

  • 00844509001560 ()

  • Total Volume: 3.0 Milliliter
291715

  • Full blood count IVD, control
No Description
TOKYO BOEKI MEDISYS INC.
20-27-0482
In Commercial Distribution

  • 04580262010345 ()
20-27-0482

  • Buffered sample diluent IVD
Lids for OT1330, 30 Lids per Case of Each
CYGNUS MEDICAL L.L.C.
LD1330
In Commercial Distribution

  • 30843356101905 ()
  • 00843356101904 ()


  • Instrument transport trolley rack
Lids for OT1016, 30 Lids per Case of Each
CYGNUS MEDICAL L.L.C.
LD1016
In Commercial Distribution

  • 30843356101790 ()
  • 00843356101799 ()


  • Instrument transport trolley rack
Lids for OT1230, 30 Lids per Case of Each
CYGNUS MEDICAL L.L.C.
LD1230
In Commercial Distribution

  • 30843356101776 ()
  • 00843356101775 ()


  • Instrument transport trolley rack
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