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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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Procleix® HIV-1/HCV/HBV Quality Control, a set of quality controls, is intended for use as an external assayed quality control material to monitor the performance of the qualitative detection of Hepatitis B Virus (HBV) DNA, Hepatitis C Virus (HCV) RNA, and Human Immunodeficiency Virus Type 1 (HIV-1) RNA with the Procleix Ultrio Elite Assay performed on the Procleix Panther System.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
HCV Positive Control
In Commercial Distribution

  • 00850032683029 ()


  • Hepatitis C virus nucleic acid IVD, control
Procleix® HIV-1/HCV/HBV Quality Control, a set of quality controls, is intended for use as an external assayed quality control material to monitor the performance of the qualitative detection of Hepatitis B Virus (HBV) DNA, Hepatitis C Virus (HCV) RNA, and Human Immunodeficiency Virus Type 1 (HIV-1) RNA with the Procleix Ultrio Elite Assay performed on the Procleix Panther System.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
HIV-1 Positive Control
In Commercial Distribution

  • 00850032683012 ()


  • HIV1 nucleic acid IVD, control
Procleix® HIV-1/HCV/HBV Quality Control, a set of quality controls, is intended for use as an external assayed quality control material to monitor the performance of the qualitative detection of Hepatitis B Virus (HBV) DNA, Hepatitis C Virus (HCV) RNA, and Human Immunodeficiency Virus Type 1 (HIV-1) RNA with the Procleix Ultrio Elite Assay performed on the Procleix Panther System.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
HIV-1/HCV/HBV Negative Control
In Commercial Distribution

  • 00850032683005 ()


  • PCR/NAT negative control IVD
30ML Platelet Rich Plasma production device.
Bimini Technologies LLC
530102-1
In Commercial Distribution

  • 00850034511979 ()
  • 00850034511962 ()


  • Haematological concentrate system
15ML Platelet Rich Plasma production device.
Bimini Technologies LLC
530101-1
In Commercial Distribution

  • 00850034511955 ()
  • 00850034511948 ()


  • Haematological concentrate system
A sterile, single use, polyester gel media containing, vacuum evacuated tube that is intended for separating and concentrating blood components along with the use of a desktop centrifuge.
Bimini Technologies LLC
HEALPRP30
In Commercial Distribution

  • 00850034511832 ()


  • Haematological concentrate system
A sterile, single use, polyester gel media containing, vacuum evacuated tube that is intended for separating and concentrating blood components along with the use of a desktop centrifuge.
Bimini Technologies LLC
HEALPRP15
In Commercial Distribution

  • 00850034511429 ()
  • 00850034511597 ()


  • Haematological concentrate system
A sterile, single use, polyester gel media containing, vacuum evacuated tube that is intended for separating and concentrating blood components along with the use of a desktop centrifuge.
Bimini Technologies LLC
HEALPRP30
In Commercial Distribution

  • 00850034511443 ()
  • 00850034511580 ()


  • Haematological concentrate system
30mL Platelet Rich Plasma production device.
Bimini Technologies LLC
PROGEN-A30
In Commercial Distribution

  • 00850034511559 ()
  • 00850034511573 ()


  • Haematological concentrate system
15ML Platelet Rich Plasma production device.
Bimini Technologies LLC
PROGEN-A15
In Commercial Distribution

  • 00850034511535 ()
  • 00850034511566 ()


  • Haematological concentrate system
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