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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Quantitative determination of IgM in human CSF and paired CSF/serum on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446035
In Commercial Distribution

  • 00842768007194 ()
OQAC11

  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
For the quantitative measurement of immunoglobulin M in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445904
In Commercial Distribution

  • 00842768006197 ()
  • 00842768020100 ()
K7058

  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
For the quantitative measurement of immunoglobulin G in human serum, plasma and cerebrospinal fluid (CSF) an urine on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445903
In Commercial Distribution

  • 00842768006180 ()
  • 00842768020094 ()
K7056

  • Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry
For the quantitative measurement of immunoglobulin A in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445901
In Commercial Distribution

  • 00842768006166 ()
  • 00842768020070 ()
K7052

  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry
Fluorescein conjugated polyclonal goat antiserum to Human IgG,IgA, and IgM (polyvalent)
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761162 ()
116202

  • Total immunoglobulin G (IgG total) IVD, control
Radial immunodiffusion plate package for Human C-3 (b1c/b1a) with standards
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761055 ()
105511

  • Complement components C3/C3c IVD, antibody
Radial immunodiffusion plate package for Human C-3 (b1c/b1a)
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761054 ()
105411

  • Complement components C3/C3c IVD, antibody
Radial immunodiffusion plate package for human IgM with standards
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761035 ()
103511

  • Total immunoglobulin M (IgM total) IVD, antibody
Radial immunodiffusion plate package for human IgM
KENT LABORATORIES INC
1
In Commercial Distribution

  • B176103411 ()
103411

  • Total immunoglobulin M (IgM total) IVD, antibody
Radial immunodiffusion plate package for human human IgG with three standards
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761015 ()
101511

  • Total immunoglobulin G (IgG total) IVD, control
Radial immunodiffusion plate package for human IgG
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761014 ()
101411

  • Total immunoglobulin G (IgG total) IVD, control
VITROS Chemistry Products IgM Reagent
ORTHO-CLINICAL DIAGNOSTICS, INC.
6801734
In Commercial Distribution

  • 10758750006830 ()
  • 20758750006837 ()
6801734

  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
VITROS Chemistry Products IgG Reagent
ORTHO-CLINICAL DIAGNOSTICS, INC.
6801733
In Commercial Distribution

  • 10758750006823 ()
  • 20758750006820 ()
6801733

  • Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry
IMMAGE Immunochemistry Systems IGA Immunoglobulin A Reagent
Beckman Coulter, Inc.
446460
In Commercial Distribution

  • 15099590230470 ()
446460

  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry
IMMAGE Immunochemistry Systems IGU Urine Immunoglobulin G Reagent
Beckman Coulter, Inc.
447020
In Commercial Distribution

  • 15099590226985 ()
447020

  • Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry
IMMAGE Immunochemistry Systems IGG Immunoglobulin G Reagent
Beckman Coulter, Inc.
446400
In Commercial Distribution

  • 15099590223885 ()
446400

  • Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry
IMMAGE Immunochemistry Systems IGALC Low Concentration ImmunoglobuIin A
Beckman Coulter, Inc.
447460
In Commercial Distribution

  • 15099590221225 ()
447460

  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry
IMMAGE Immunochemistry Systems IGMLC Low Concentration ImmunoglobuIin M
Beckman Coulter, Inc.
447470
In Commercial Distribution

  • 15099590221218 ()
447470

  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent
Beckman Coulter, Inc.
447610
In Commercial Distribution

  • 15099590221195 ()
447610

  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
IgM
Beckman Coulter, Inc.
OSR61173
In Commercial Distribution

  • 15099590011598 ()


  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
IgG
Beckman Coulter, Inc.
OSR61172
In Commercial Distribution

  • 15099590011581 ()


  • Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry
IgA
Beckman Coulter, Inc.
OSR61171
In Commercial Distribution

  • 15099590011574 ()


  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry
Monoclonal Mouse Anti-Human Amyloid A Clone mc1
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
M0759
In Commercial Distribution

  • 05700572005339 ()

  • Total Volume: 1 Milliliter


  • Amyloid A component IVD, antibody
NCL-L-SP-A is intended for the qualitative identification by light microscopy of human surfactant protein A in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
SP-A-L-U
In Commercial Distribution

  • 05055331321336 ()
NCL-L-SP-A

  • Surfactant apoprotein A IVD, antibody
FLEX Monoclonal Mouse Anti-Human Amyloid A Clone mc1 Ready-to-Use (Dako Omnis)
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
GA605
In Commercial Distribution

  • 05700572034179 ()

  • Total Volume: 12 Milliliter


  • Amyloid A component IVD, antibody
FLEX Monoclonal Mouse Anti-Human Amyloid A Clone mc1 Ready-to-Use (Dako Autostainer/ Autostainer Plus)
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
IS605
In Commercial Distribution

  • 05700572030331 ()

  • 20-30 Tests


  • Amyloid A component IVD, antibody
FLEX Monoclonal Mouse Anti-Human Amyloid A Clone mc1 Ready-to-Use (Link)
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
IR605
In Commercial Distribution

  • 05700572030218 ()

  • 40-60 Tests


  • Amyloid A component IVD, antibody
No Description
Fisher Diagnostics
TR70121
In Commercial Distribution

  • 00845275003383 ()
  • 00845275006278 ()


  • Beta-hexosaminidase A (HexA) IVD, reagent
No Description
CHARMANT INC.
30-0702
In Commercial Distribution

  • 00883475953176 ()


  • Surgical A/V-shaped microvessel clamp
No Description
CHARMANT INC.
30-0701
In Commercial Distribution

  • 00883475953121 ()


  • Surgical A/V-shaped microvessel clamp
No Description
LANDANGER
DC81010-00
In Commercial Distribution

  • 03661219416340 ()


  • Surgical A/V-shaped microvessel clamp
No Description
LANDANGER
DC41817-17
In Commercial Distribution

  • 03661219363668 ()


  • Surgical A/V-shaped microvessel clamp
Amyloid A Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB28090 ()
BSB 2809

  • Amyloid A component IVD, control
Amyloid A is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 1 ml
In Commercial Distribution

  • B502BSB28080 ()
BSB 2808

  • Amyloid A component IVD, antibody
Amyloid A is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 0.5 ml
In Commercial Distribution

  • B502BSB28070 ()
BSB 2807

  • Amyloid A component IVD, antibody
Amyloid A is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 0.1 ml
In Commercial Distribution

  • B502BSB28060 ()
BSB 2806

  • Amyloid A component IVD, antibody
Tinto Amyloid A is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 15 ml
In Commercial Distribution

  • B502BSB28050 ()
BSB 2805

  • Amyloid A component IVD, antibody
Tinto Amyloid A is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 7 ml
In Commercial Distribution

  • B502BSB28040 ()
BSB 2804

  • Amyloid A component IVD, antibody
Tinto Amyloid A is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 3 ml
In Commercial Distribution

  • B502BSB28030 ()
BSB 2803

  • Amyloid A component IVD, antibody
Amyloid A Control Slides
BIO SB, INC.
BSB-9014-CS
In Commercial Distribution

  • B502BSB9014CS0 ()
BSB-9014-CS

  • Amyloid A component IVD, control
Micro Bulldog Clamp B2-V (65-6941A)
Anmuth Medical International, LLC
18-020-1A
In Commercial Distribution

  • 08403207000422 ()

  • Length: 2 Inch
18-020-1A

  • Surgical A/V-shaped microvessel clamp
Micro Bulldog Clamp RD-S (65-6996A)
Anmuth Medical International, LLC
18-020-6A
In Commercial Distribution

  • 08403207000446 ()

  • Length: 2 Inch
18-020-6A

  • Surgical A/V-shaped microvessel clamp
Micro Bulldog Clamp HD-S (65-6995A)
Anmuth Medical International, LLC
18-020-5A
In Commercial Distribution

  • 08403207000439 ()

  • Length: 2 Inch
18-020-5A

  • Surgical A/V-shaped microvessel clamp
ZENKER DISSECTING FORCEPS FIG. 2 LENGTH 295 MM
Gimmi GmbH
AC.1472.02
In Commercial Distribution

  • 04049047012535 ()
AC.1472.02

  • Surgical A/V-shaped microvessel clamp
ZENKER DISSECTING FORCEPS FIG. 1 LENGTH 295 MM
Gimmi GmbH
AC.1472.01
In Commercial Distribution

  • 04049047012528 ()
AC.1472.01

  • Surgical A/V-shaped microvessel clamp
MINI-GEMINI DISSECTING/ LIGATURE FORCEPS CURVED LENGTH 250 MM
Gimmi GmbH
AC.1456.25
In Commercial Distribution

  • 04049047012375 ()
AC.1456.25

  • Surgical A/V-shaped microvessel clamp
GEMINI DISSECTING/ LIGATURE FORCEPS CURVED LENGTH 250 MM
Gimmi GmbH
AC.1454.25
In Commercial Distribution

  • 04049047012337 ()
AC.1454.25

  • Surgical A/V-shaped microvessel clamp
GEMINI DISSECTING/ LIGATURE FORCEPS CURVED LENGTH 230 MM
Gimmi GmbH
AC.1454.23
In Commercial Distribution

  • 04049047012320 ()
AC.1454.23

  • Surgical A/V-shaped microvessel clamp
GEMINI DISSECTING/ LIGATURE FORCEPS CURVED LENGTH 200 MM
Gimmi GmbH
AC.1454.20
In Commercial Distribution

  • 04049047012313 ()
AC.1454.20

  • Surgical A/V-shaped microvessel clamp
GEMINI DISSECTING/ LIGATURE FORCEPS CURVED LENGTH 180 MM
Gimmi GmbH
AC.1454.18
In Commercial Distribution

  • 04049047012306 ()
AC.1454.18

  • Surgical A/V-shaped microvessel clamp
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