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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No Description
BIOCARE MEDICAL LLC
PM388H
In Commercial Distribution

  • 00847627034977 ()


  • Napsin A IVD, antibody
No Description
BIOCARE MEDICAL LLC
NPAI388T80
In Commercial Distribution

  • 00847627039316 ()


  • Napsin A IVD, antibody
No Description
BIOCARE MEDICAL LLC
NPAI388T40
In Commercial Distribution

  • 00847627039309 ()


  • Napsin A IVD, antibody
No Description
BIOCARE MEDICAL LLC
ALI388G7
In Commercial Distribution

  • 00847627033505 ()


  • Napsin A IVD, antibody
No Description
BIOCARE MEDICAL LLC
ALI010G7
In Commercial Distribution

  • 00847627030207 ()


  • Chromogranin A IVD, antibody
LP(A) - ADVIA Chem. - CAL
Siemens Healthcare Diagnostics Inc.
10285017
In Commercial Distribution

  • 00630414558257 ()
4865268

  • Lipoprotein A IVD, calibrator
Assayed control for Lp(a) assay on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10873687
In Commercial Distribution

  • 00630414287447 ()
  • 00630414285016 ()
OQCW07

  • Lipoprotein A IVD, control
Calibration of Lp(a) assay on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10873686
In Commercial Distribution

  • 00630414287430 ()
  • 00630414285009 ()
OQCV07

  • Lipoprotein A IVD, calibrator
No Description
BIOCARE MEDICAL LLC
OPAI388T60
In Commercial Distribution

  • 00847627025579 ()


  • Napsin A IVD, antibody
No Description
BIOCARE MEDICAL LLC
AVI388G
In Commercial Distribution

  • 00847627024671 ()


  • Napsin A IVD, antibody
No Description
BIOCARE MEDICAL LLC
PP434AA
In Commercial Distribution

  • 00847627012227 ()


  • Napsin A IVD, antibody
No Description
BIOCARE MEDICAL LLC
PM388AA
In Commercial Distribution

  • 00847627011817 ()


  • Napsin A IVD, antibody
No Description
BIOCARE MEDICAL LLC
PM171AA
In Commercial Distribution

  • 00847627011305 ()


  • Inhibin A IVD, antibody
No Description
BIOCARE MEDICAL LLC
IPI388G10
In Commercial Distribution

  • 00847627008961 ()


  • Napsin A IVD, antibody
No Description
BIOCARE MEDICAL LLC
CM388CK
In Commercial Distribution

  • 00847627007346 ()


  • Napsin A IVD, antibody
No Description
BIOCARE MEDICAL LLC
CM388AK
In Commercial Distribution

  • 00847627007339 ()


  • Napsin A IVD, antibody
No Description
BIOCARE MEDICAL LLC
CM171C
In Commercial Distribution

  • 00847627006721 ()


  • Inhibin A IVD, antibody
No Description
BIOCARE MEDICAL LLC
CM171B
In Commercial Distribution

  • 00847627006714 ()


  • Inhibin A IVD, antibody
No Description
BIOCARE MEDICAL LLC
API3043AA
In Commercial Distribution

  • 00847627004000 ()


  • Napsin A IVD, antibody
No Description
BIOCARE MEDICAL LLC
ACI3043C
In Commercial Distribution

  • 00847627002778 ()


  • Napsin A IVD, antibody
No Description
BIOCARE MEDICAL LLC
ACI3043A
In Commercial Distribution

  • 00847627002761 ()


  • Napsin A IVD, antibody
No Description
BIOCARE MEDICAL LLC
AVI434G
In Commercial Distribution

  • 00847627023902 ()


  • Napsin A IVD, antibody
Lipoprotein a (LP(a)) Calibrator Atellica CH - CAL 5 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
11099433
In Commercial Distribution

  • 00630414597546 ()
11099433

  • Lipoprotein A IVD, calibrator
Clone R1010
NOVODIAX, INC.
K47043-015
Not in Commercial Distribution

  • 00850000596733 ()

  • Total Volume: 15 Milliliter
K47043-015

  • Napsin A IVD, antibody
Clone R1010
NOVODIAX, INC.
K47043-005
Not in Commercial Distribution

  • 00850000596726 ()

  • Total Volume: 5 Milliliter
K47043-005

  • Napsin A IVD, antibody
Clone R1010
NOVODIAX, INC.
K32043-015
Not in Commercial Distribution

  • 00850000596719 ()

  • Total Volume: 15 Milliliter
K32043-015

  • Napsin A IVD, antibody
Clone R1010
NOVODIAX, INC.
K32043-005
Not in Commercial Distribution

  • 00850000596702 ()

  • Total Volume: 5 Milliliter
K32043-005

  • Napsin A IVD, antibody
Clone R1004
NOVODIAX, INC.
K32035-015
Not in Commercial Distribution

  • 00850000596696 ()

  • Total Volume: 15 Milliliter
K32035-015

  • Chromogranin A IVD, antibody
Clone R1004
NOVODIAX, INC.
K32035-005
Not in Commercial Distribution

  • 00850000596689 ()

  • Total Volume: 5 Milliliter
K32035-005

  • Chromogranin A IVD, antibody
This product is intended for use in the calibration of Lipoprotein(a) assays.
RANDOX LABORATORIES LIMITED
LP3404
In Commercial Distribution

  • 05055273204438 ()
LP3404

  • Lipoprotein A IVD, calibrator
Randox Lipoprotein(a) level 3 control is based on lyophilised human serum containing Lipoprotein(a).
RANDOX LABORATORIES LIMITED
LP3406
In Commercial Distribution

  • 05055273204445 ()


  • Lipoprotein A IVD, control
NCL-L-InhibinA is intended for the qualitative identification by light microscopy of inhibin alpha molecules in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
INHIBINA-L-CE
In Commercial Distribution

  • 05055331318350 ()
NCL-L-InhibinA

  • Inhibin A IVD, antibody
NCL-L-Napsin A is intended for the qualitative identification by light microscopy of Napsin A molecules in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
NAPSINA-L-CE
In Commercial Distribution

  • 05055331305572 ()
NCL-L-Napsin A

  • Napsin A IVD, antibody
Chromogranin A (5H7) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human chromogranin A in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0430
In Commercial Distribution

  • 05055331304124 ()
PA0430

  • Chromogranin A IVD, antibody
Chromogranin A (5H7) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human chromogranin A in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes BOND-MAX, BOND-III, and BOND-PRIME systems).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0515-U
In Commercial Distribution

  • 05055331335197 ()
PA0515-U

  • Chromogranin A IVD, antibody
Inhibin Alpha (R1) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human inhibin alpha protein in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes BOND-MAX, BOND-III, and BOND-PRIME systems).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0488-U
In Commercial Distribution

  • 05055331335166 ()
PA0448-U

  • Inhibin A IVD, antibody
Napsin A (IP64) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human napsin A in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes BOND-MAX, BOND-III, and BOND-PRIME systems).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0064-U
In Commercial Distribution

  • 05055331334312 ()
PA0064-U

  • Napsin A IVD, antibody
NCL-L-NapsinA-U is intended for the qualitative identification by light microscopy of Napsin A molecules in parrafin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
NAPSINA-L-U
In Commercial Distribution

  • 05055331334039 ()
NCL-L-NAPSINA-U

  • Napsin A IVD, antibody
NCL-L-InhibinA-U is intended for the qualitative identification by light microscopy of inhibin alpha molecules in parrafin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
INHIBINA-L-U
In Commercial Distribution

  • 05055331333889 ()
NCL-L-INHIBINA-U

  • Inhibin A IVD, antibody
NCL-L-CHROM-430-U is intended for the qualitative identification by light microscopy of chromogranin A molecules in parrafin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
CHROM-430-L-U
In Commercial Distribution

  • 05055331333537 ()
NCL-L-CHROM-430-U

  • Chromogranin A IVD, antibody
Monoclonal Mouse Anti-Human Chromogranin A Clone DAK-A3
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
M0869
In Commercial Distribution

  • 05700572013358 ()

  • Total Volume: 0.2 Milliliter


  • Chromogranin A IVD, antibody
Monoclonal Mouse Anti-Human Chromogranin A Clone DAK-A3
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
M0869
In Commercial Distribution

  • 05700572005957 ()

  • Total Volume: 1 Milliliter


  • Chromogranin A IVD, antibody
FLEX Monoclonal Mouse Anti-Human Inhibin a Clone R1 Ready-to-Use (Link)
AGILENT TECHNOLOGIES, INC.
IR058
In Commercial Distribution

  • 05700571101711 ()

  • 40-60 Tests


  • Inhibin A IVD, antibody
Clone R1010
NOVODIAX, INC.
K47043-015
In Commercial Distribution


  • Total Volume: 15 Milliliter


  • Napsin A IVD, antibody
Clone R1010
NOVODIAX, INC.
K47043-005
In Commercial Distribution


  • Total Volume: 5 Milliliter


  • Napsin A IVD, antibody
Clone R1010
NOVODIAX, INC.
H32043-R015
In Commercial Distribution


  • Total Volume: 15 Milliliter
K32043-015

  • Napsin A IVD, antibody
Clone R1010
NOVODIAX, INC.
H32043-R005
In Commercial Distribution


  • Total Volume: 5 Milliliter
K32043-005

  • Napsin A IVD, antibody
Clone R1004
NOVODIAX, INC.
H32035-R015
In Commercial Distribution


  • Total Volume: 15 Milliliter
K32035-015

  • Chromogranin A IVD, antibody
Clone R1004
NOVODIAX, INC.
H32035-R005
In Commercial Distribution


  • Total Volume: 5 Milliliter
K32035-005

  • Chromogranin A IVD, antibody
No Description
BIOGENEX LABORATORIES
MU446-UC
In Commercial Distribution

  • 00850646007587 ()

  • Total Volume: 1 Milliliter
MU446-UC

  • Inhibin A IVD, antibody
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