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 IgG subclass 2 in human serum on BN II and BN ProSpec® Systems
Siemens Healthcare Diagnostics Products GmbH
10446169
In Commercial Distribution

  • 00842768008467 ()
OQXK09

  • Immunoglobulin G subclass (IgG subclass) IVD, reagent
Quantitative determination of IgG subclass 1 in human serum on BN II and BN ProSpec® Systems
Siemens Healthcare Diagnostics Products GmbH
10446168
In Commercial Distribution

  • 00842768008450 ()
OQXI09

  • Immunoglobulin G subclass (IgG subclass) IVD, reagent
Quantitative determination of IgG subclass 3 in human serum and plasma on BN II and BN ProSpec® Systems
Siemens Healthcare Diagnostics Products GmbH
10445972
In Commercial Distribution

  • 00842768006708 ()
OPAV03

  • Immunoglobulin G subclass (IgG subclass) IVD, reagent
Quantitative determination of IgG subclass 4 in human serum and plasma on BN II and BN ProSpec® Systems
Siemens Healthcare Diagnostics Products GmbH
10445971
In Commercial Distribution

  • 00842768006692 ()
OPAU03

  • Immunoglobulin G subclass (IgG subclass) IVD, reagent
For the quantitative measurement of immunoglobulin G subclass 4 in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445914
In Commercial Distribution

  • 00842768006296 ()
  • 00842768020230 ()
K7083

  • Immunoglobulin G subclass (IgG subclass) IVD, reagent
For the quantitative measurement of immunoglobulin G subclass 3 in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445913
In Commercial Distribution

  • 00842768006289 ()
  • 00842768020209 ()
K7082

  • Immunoglobulin G subclass (IgG subclass) IVD, reagent
For the quantitative measurement of immunoglobulin G subclass 2 in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445912
In Commercial Distribution

  • 00842768006272 ()
  • 00842768020193 ()
K7081

  • Immunoglobulin G subclass (IgG subclass) IVD, reagent
For the quantitative measurement of immunoglobulin G subclass 1 in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445911
In Commercial Distribution

  • 00842768006265 ()
  • 00842768020186 ()
K7080

  • Immunoglobulin G subclass (IgG subclass) IVD, reagent
HSV-1 & HSV-2 Control Lot Data
BIO-RAD LABORATORIES, INC.
6633340
In Commercial Distribution

  • 00847865000932 ()

  • 1 Each
6633340

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, control
HSV-1 & HSV-2 IgG Control Set
BIO-RAD LABORATORIES, INC.
6633330
In Commercial Distribution

  • 00847865000925 ()

  • 4 Vials
  • Total Volume: 1.5 Milliliter
6633330

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, control
DV/DM COV2G/CV2G POS/NEG CTRL
Siemens Healthcare Diagnostics Inc.
11417773
Not in Commercial Distribution

  • 00630414298405 ()
  • 00630414607054 ()
KC873

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control
No Description
THE BINDING SITE GROUP LIMITED
EA118.A
In Commercial Distribution

  • 05051700019613 ()


  • Clostridium tetani immunoglobulin G (IgG) antibody IVD, reagent
AccuDiag™Measles IgM ELISA Kit A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to Measles virus in a clinical specimen, using an enzyme immunoassay (EIA) method.
Diagnostic Automation, Inc.
DACD 1409-1
In Commercial Distribution

  • 00894175000527 ()

  • 96 Tests
1409-1

  • Measles virus immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA)
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Controls
ORTHO CLINICAL DIAGNOSTICS
6199921
In Commercial Distribution

  • 10758750033379 ()
6199921

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control
T. CRUZI ELISA TEST SYSTEM 192T
ORTHO-CLINICAL DIAGNOSTICS, INC.
6902594
In Commercial Distribution

  • 10758750007875 ()
6902594

  • Trypanosoma cruzi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
T. CRUZI ELISA TEST SYSTEM 192T WW
ORTHO-CLINICAL DIAGNOSTICS, INC.
6902412
In Commercial Distribution

  • 10758750007745 ()
6902412

  • Trypanosoma cruzi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
T.CRUZI ELISA Test System 2400T
ORTHO-CLINICAL DIAGNOSTICS, INC.
6901969
In Commercial Distribution

  • 10758750007479 ()
6901969

  • Trypanosoma cruzi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
T.CRUZI ELISA Test System 480T
ORTHO-CLINICAL DIAGNOSTICS, INC.
6901968
In Commercial Distribution

  • 10758750007462 ()
6901968

  • Trypanosoma cruzi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
VITROS Immunodiagnostic Products Anti-SARS-COV-2 IgG Controls
ORTHO CLINICAL DIAGNOSTICS
6199974
In Commercial Distribution

  • 20758750034557 ()
  • 10758750034550 ()
6199974

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control
Liner #M for Mobile Liner Dia. 40 mm
LIMACORPORATE SPA
5885.09.040
In Commercial Distribution

  • 08033390086332 ()

  • #M Dia. 40 mm
5885.09.040

  • Ceramic acetabular liner
Liner #L for Mobile Liner Dia. 42 mm
LIMACORPORATE SPA
5885.09.042
In Commercial Distribution

  • 08033390020060 ()

  • #L Dia. 42 mm
5885.09.042

  • Ceramic acetabular liner
The Measles Virus IgG Avidity ELISA is intended to indicate the Measles-specific IgG avidity in human serum or plasma (citrate, heparin) to differentiate between acute and past infection.
DRG International Inc
EIA-5967
Not in Commercial Distribution

  • 00840239059673 ()
EIA-5967

  • Measles virus immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA)
The Mumps Virus IgM ELISA is intended for the qualitative determination of IgM class antibodies against Mumps Virus in human serum or plasma (citrate, heparin).
DRG International Inc
EIA-3847
In Commercial Distribution

  • 00840239038470 ()
EIA-3847

  • Mumps virus immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA)
The Mumps Virus IgG ELISA is intended for the qualitative determination of IgG class antibodies against Mumps Virus in human serum or plasma (citrate, heparin).
DRG International Inc
EIA-3846
In Commercial Distribution

  • 00840239038463 ()

  • Conjugate
  • Diluent G
  • Total Volume: 20 Milliliter
  • Wash Buffer
  • Cut Off
  • Total Volume: 100 Milliliter
  • Total Volume: 15 Milliliter
  • Total Volume: 50 Milliliter
  • Total Volume: 3 Milliliter
  • Stop Solution
  • Controls +/-
  • Substrate TMB
  • Total Volume: 2 Milliliter
EIA-3846

  • Mumps virus immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA)
The Measles Virus IgG ELISA is intended for the qualitative determination of IgG class antibodies against Measles Virus in human serum or plasma (citrate, heparin).
DRG International Inc
EIA-3844
In Commercial Distribution

  • 00840239038449 ()

  • Total Volume: 2 Milliliter
  • Substrate TMB
  • Cut Off
  • Total Volume: 50 Milliliter
  • Total Volume: 3 Milliliter
  • Conjugate
  • Controls +/-
  • Total Volume: 20 Milliliter
  • Total Volume: 15 Milliliter
  • Diluent G
  • Stop Solution
  • Wash Buffer
  • Total Volume: 100 Milliliter
EIA-3844

  • Measles virus immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA)
LINEAGE® CERAMIC LINER 36mm X 64-68mm GROUP 4
Microport Orthopedics Inc.
74003664
In Commercial Distribution

  • 74003664 ()
  • M684740036641 ()

  • Lumen/Inner Diameter: 36 Millimeter
74003664

  • Ceramic acetabular liner
LINEAGE® CERAMIC LINER 32mm X 64-68mm GROUP 4
Microport Orthopedics Inc.
74003264
In Commercial Distribution

  • 74003264 ()
  • M684740032641 ()

  • Lumen/Inner Diameter: 32 Millimeter
74003264

  • Ceramic acetabular liner
LINEAGE® CERAMIC LINER 28mm X 64-68mm GROUP 4
Microport Orthopedics Inc.
74002864
In Commercial Distribution

  • 74002864 ()
  • M684740028641 ()

  • Lumen/Inner Diameter: 28 Millimeter
74002864

  • Ceramic acetabular liner
LINEAGE® CERAMIC LINER 36mm X 58-62mm GROUP 3
Microport Orthopedics Inc.
73003658
In Commercial Distribution

  • 73003658 ()
  • M684730036581 ()

  • Lumen/Inner Diameter: 36 Millimeter
73003658

  • Ceramic acetabular liner
LINEAGE® CERAMIC LINER 32mm X 58-62mm GROUP 3
Microport Orthopedics Inc.
73003258
In Commercial Distribution

  • 73003258 ()
  • M684730032581 ()

  • Lumen/Inner Diameter: 32 Millimeter
73003258

  • Ceramic acetabular liner
LINEAGE® CERAMIC LINER 28mm X 58-62mm GROUP 3
Microport Orthopedics Inc.
73002858
In Commercial Distribution

  • 73002858 ()
  • M684730028581 ()

  • Lumen/Inner Diameter: 28 Millimeter
73002858

  • Ceramic acetabular liner
LINEAGE® CERAMIC LINER 32mm X 52-56mm GROUP 2
Microport Orthopedics Inc.
72003252
In Commercial Distribution

  • 72003252 ()
  • M684720032521 ()

  • Lumen/Inner Diameter: 32 Millimeter
72003252

  • Ceramic acetabular liner
LINEAGE® CERAMIC LINER 28mm X 52-56mm GROUP 2
Microport Orthopedics Inc.
72002852
In Commercial Distribution

  • 72002852 ()
  • M684720028521 ()

  • Lumen/Inner Diameter: 28 Millimeter
72002852

  • Ceramic acetabular liner
LINEAGE® CERAMIC LINER 28mm X 46-50mm GROUP 1
Microport Orthopedics Inc.
71002846
In Commercial Distribution

  • 71002846 ()
  • M684710028461 ()

  • Lumen/Inner Diameter: 28 Millimeter
71002846

  • Ceramic acetabular liner
ACETABULAR LINER 22MM Inner Diameter 63-70MM Outer Diameter 20 DEGREE
Smith & Nephew, Inc.
71342263
In Commercial Distribution

  • 03596010001788 ()
71342263

  • Ceramic acetabular liner
ACETABULAR LINER 32MM Inner Diameter 56-62MM Outer Diameter 20 DEGREE
Smith & Nephew, Inc.
71343256
In Commercial Distribution

  • 03596010197986 ()
71343256

  • Ceramic acetabular liner
ACETABULAR LINER 28MM Inner Diameter 63-70MM Outer Diameter 20 DEGREE
Smith & Nephew, Inc.
71342863
In Commercial Distribution

  • 03596010197979 ()
71342863

  • Ceramic acetabular liner
ACETABULAR LINER 28MM Inner Diameter 56-62MM Outer Diameter 20 DEGREE
Smith & Nephew, Inc.
71342856
In Commercial Distribution

  • 03596010197962 ()
71342856

  • Ceramic acetabular liner
ACETABULAR LINER 28MM Inner Diameter 50-54MM Outer Diameter 20 DEGREE
Smith & Nephew, Inc.
71342850
In Commercial Distribution

  • 03596010197955 ()
71342850

  • Ceramic acetabular liner
ACETABULAR LINER 26MM Inner Diameter 63-70MM Outer Diameter 20 DEGREE
Smith & Nephew, Inc.
71342663
In Commercial Distribution

  • 03596010197931 ()
71342663

  • Ceramic acetabular liner
ACETABULAR LINER 26MM Inner Diameter 56-62MM Outer Diameter 20 DEGREE
Smith & Nephew, Inc.
71342656
In Commercial Distribution

  • 03596010197924 ()
71342656

  • Ceramic acetabular liner
ACETABULAR LINER 26MM Inner Diameter 50-54MM Outer Diameter 20 DEGREE
Smith & Nephew, Inc.
71342650
In Commercial Distribution

  • 03596010197917 ()
71342650

  • Ceramic acetabular liner
ACETABULAR LINER 26MM Inner Diameter 46-48MM Outer Diameter 20 DEGREE
Smith & Nephew, Inc.
71342646
In Commercial Distribution

  • 03596010197900 ()
71342646

  • Ceramic acetabular liner
ACETABULAR LINER 22MM Inner Diameter 56-62MM Outer Diameter 20 DEGREE
Smith & Nephew, Inc.
71342256
In Commercial Distribution

  • 03596010197887 ()
71342256

  • Ceramic acetabular liner
ACETABULAR LINER 22MM Inner Diameter 50-54MM Outer Diameter 20 DEGREE
Smith & Nephew, Inc.
71342250
In Commercial Distribution

  • 03596010197870 ()
71342250

  • Ceramic acetabular liner
ACETABULAR LINER 22MM Inner Diameter 46-48MM Outer Diameter 20 DEGREE
Smith & Nephew, Inc.
71342246
In Commercial Distribution

  • 03596010197863 ()
71342246

  • Ceramic acetabular liner
ACETABULAR LINER 22MM Inner Diameter 44-45MM Outer Diameter 20 DEGREE
Smith & Nephew, Inc.
71342244
In Commercial Distribution

  • 03596010197856 ()
71342244

  • Ceramic acetabular liner
ACETABULAR LINER 22MM Inner Diameter 46-48MM Outer Diameter 0 DEGREE
Smith & Nephew, Inc.
71342046
In Commercial Distribution

  • 03596010197818 ()
71342046

  • Ceramic acetabular liner
ACETABULAR LINER 22MM Inner Diameter 44-45MM Outer Diameter 0 DEGREE
Smith & Nephew, Inc.
71342044
In Commercial Distribution

  • 03596010197801 ()
71342044

  • Ceramic acetabular liner
ACETABULAR LINER 28MM Inner Diameter 63-70MM Outer Diameter 0 DEGREE
Smith & Nephew, Inc.
71340863
In Commercial Distribution

  • 03596010197795 ()
71340863

  • Ceramic acetabular liner
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