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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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MERIFLUOR Cryptosporidium/Giardia (MERIFLUOR C/G) is an in vitro direct immunofluorescent detection procedure for the simultaneous detection of Cryptosporidium oocysts and Giardia cysts in fecal material.
MERIDIAN BIOSCIENCE, INC.
250050
In Commercial Distribution

  • 00840733101113 ()
250050

  • Multiple faecal parasite antigen IVD, kit, direct fluorescent test (DFT)
Pointe Creatine Kinase packaged for use on the BS480. 4x40mL, 4x15mL Kit. For the quantitative determination of creatine kinase activity in serum. For in vitro diagnostic use only.
POINTE SCIENTIFIC, INC.
14-C7522-220
In Commercial Distribution

  • 00811727015785 ()
14-C7522-220

  • Total creatine kinase (CK) IVD, kit, enzyme spectrophotometry
Creatinine Enzymatic, for the quantitative enzymatic determination of creatinine in serum and urine. For In Vitro Diagnostic Use Only. Size: 1 x 750 mL, 1 x 250 mL.
POINTE SCIENTIFIC, INC.
C7548-1L
In Commercial Distribution

  • 00811727014474 ()
C7548-1L

  • Creatinine IVD, kit, enzyme spectrophotometry
For the quantitative determination of urea nitrogen in serum using the Polychem 180 analyzer. For in vitro diagnostic use only. 6 x 51 ml, 4 x 20 ml
Medtest Dx, Inc.
BUN505
In Commercial Distribution

  • 00817439020291 ()
BUN505

  • Urea IVD, kit, enzyme spectrophotometry
For the quantitative determination of urea nitrogen in serum using the Mindray BS-480 analyzer. For in vitro diagnostic use only. 8 x 60 ml, 8 x 15 ml
Medtest Dx, Inc.
BUN480
In Commercial Distribution

  • 00817439020284 ()
BUN480

  • Urea IVD, kit, enzyme spectrophotometry
For the quantitative determination of alkaline phosphatase in human serum using the Mindray BS-480 analyzer. In vitro diagnostic medical device. 5 x 60 ml, 5 x 15 ml.
Medtest Dx, Inc.
ALT480
In Commercial Distribution

  • 00817439020154 ()
ALT480

  • Alanine aminotransferase (ALT) IVD, kit, enzyme spectrophotometry
Biopsy Punch, Tischler-Burke Baby Gold Series 4.5 X 1.5MM OVAL BITE 9.75 in
MCKESSON MEDICAL-SURGICAL INC.
43-1-1443
In Commercial Distribution

  • 00612479161382 ()


  • Gynaecological biopsy forceps, reusable
Uni-Flo™ Fenestrated Catheter – 10 inch (254mm), 19 GA x 36 in (914mm)
SUMMIT MEDICAL PRODUCTS, INC.
220491
In Commercial Distribution

  • 20857595005439 ()
  • 00857595005435 ()

  • Length: 254 Millimeter
220491

  • Anaesthesia conduction catheter
Uni-Flo™ Fenestrated Catheter – 5 inch (127mm), 19 GA x 36 in (914mm)
SUMMIT MEDICAL PRODUCTS, INC.
220490
In Commercial Distribution

  • 20857595005422 ()
  • 00857595005428 ()

  • Length: 127 Millimeter
220490

  • Anaesthesia conduction catheter
For the Quantitative Colorimetric Determination of Urea Nitrogen in Serum, Plasma or Urine.
STANBIO LABORATORY, L.P.
0580-250
In Commercial Distribution

  • 00657498001097 ()
0580-250

  • Urea IVD, kit, enzyme spectrophotometry
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