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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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R3 36MM ID US CERAMIC ACET LINER MM66/68
Smith & Nephew, Inc.
71338966
In Commercial Distribution

  • 00885556022313 ()
71338966

  • Ceramic acetabular liner
ACETABULAR LINER 32MM Inner Diameter 63-70MM Outer Diameter 0 DEGREE
Smith & Nephew, Inc.
71340263
In Commercial Distribution

  • 00885556022122 ()
71340263

  • Ceramic acetabular liner
R3 36MM ID US CERAMIC ACET LINER MM56
Smith & Nephew, Inc.
71338956
In Commercial Distribution

  • 00885556022115 ()
71338956

  • Ceramic acetabular liner
ACETABULAR LINER 26MM Inner Diameter 63-70MM Outer Diameter 0 DEGREE
Smith & Nephew, Inc.
71340663
In Commercial Distribution

  • 00885556022054 ()
71340663

  • Ceramic acetabular liner
R3 32MM ID US CERAMIC ACET LINER MM48
Smith & Nephew, Inc.
71338948
In Commercial Distribution

  • 00885556022047 ()
71338948

  • Ceramic acetabular liner
ACETABULAR LINER 22MMID 50-54MMOD 0 DEG
Smith & Nephew, Inc.
71342050
In Commercial Distribution

  • 00885556021958 ()
71342050

  • Ceramic acetabular liner
R3 36MM ID US CERAMIC ACET LINER MM54
Smith & Nephew, Inc.
71338954
In Commercial Distribution

  • 00885556021927 ()
71338954

  • Ceramic acetabular liner
ACETABULAR LINER 32MM ID 56-62MM OD 0 DEGREE
Smith & Nephew, Inc.
71340256
In Commercial Distribution

  • 00885556021903 ()
71340256

  • Ceramic acetabular liner
IgG conjugate for use with ImmunoFA Toxoplasma IgG kit.
Genbio
800-1202
In Commercial Distribution

  • 00613745012025 ()

  • 3.5 mL
1202

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, reagent
The ZEUS AtheNA Multi-Lyte® Herpes Simplex Virus (HSV)-1 & 2 IgG Plus Test System is intended for the qualitative detection of presence or absence of IgG antibodies to HSV-1 and HSV-2 in human serum. The test is indicated for sexually active adults and expectant mothers, as an aid for presumptively diagnosing Herpes Simplex 1 and Herpes Simplex 2. The predictive value of positive or negative results depends on the population’s prevalence and the pretest likelihood of HSV-1 and HSV-2. The test is not intended for donor screening or for self testing. The performance of this assay has not been established for use in a pediatric population, neonates, immunocompromised patients, for use by point of care facilities or for use with automated equipment. This test is for In Vitro diagnostic use only.
ZEUS SCIENTIFIC, INC.
A97101G
In Commercial Distribution

  • 00845533000055 ()
A97101G

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
Captia™ Herpes Group IgG
CLARK LABORATORIES, INC.
2346600
In Commercial Distribution

  • 05391516746496 ()

  • 96 Tests
2346600

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
HSV G
In Commercial Distribution

  • 00850487007333 ()
Q01-160

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
HSV G
In Commercial Distribution

  • 00850487007142 ()
Q01-160

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
HSV I and II IgG Ab - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381274
In Commercial Distribution

  • 00630414964171 ()
LKHS1

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
IMMULITE® 2000 Systems Herpes I and II IgG
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381333
In Commercial Distribution

  • 00630414999784 ()
L2KHVG6

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
DV/DM COV2G/CV2G CAL
Siemens Healthcare Diagnostics Inc.
11417772
Not in Commercial Distribution

  • 00630414298399 ()
  • 00630414607047 ()
KC872

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator
HSV-1 & HSV-2 Assay Protocol File CD, SW4.1_v2
BIO-RAD LABORATORIES, INC.
SW4.1_V2
In Commercial Distribution

  • 00847865010993 ()

  • 1 Each
6653370E

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
HSV IgG EIA
Bio-RAD Laboratories, Inc.
25179
In Commercial Distribution

  • 00847865010740 ()

  • 96 Tests
25179

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Manual & CDs, HSV-1 & HSV-2 IgG IFU, SW4_v2
BIO-RAD LABORATORIES, INC.
SW4_V2
In Commercial Distribution

  • 00847865004725 ()

  • 1 Each
6653360E

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
HSV-1 & HSV-2 Assay Protocol File CD, SW4_v2
BIO-RAD LABORATORIES, INC.
SW4_V2
In Commercial Distribution

  • 00847865002479 ()

  • 1 Each
6653370D

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
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