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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 ACETABULAR - 00885556021309

R3 36MM ID US CERAMIC ACET LINER MM62
Smith & Nephew, Inc.
71338962
In Commercial Distribution

  • 00885556021309 ()
71338962

  • Ceramic acetabular liner

REFLECTION - 00885556020975

ALUMINA CERAMIC LINER 32ID 50-54OD
Smith & Nephew, Inc.
71338450
Not in Commercial Distribution

  • 00885556020975 ()
71338450

  • Ceramic acetabular liner

NA - 00885556020906

ACETABULAR LINER 26MM Inner Diameter 50-54MM Outer Diameter 0 DEGREE
Smith & Nephew, Inc.
71340650
In Commercial Distribution

  • 00885556020906 ()
71340650

  • Ceramic acetabular liner

R3 ACETABULAR - 00885556020685

R3 36MM ID US CERAMIC ACET LINER MM60
Smith & Nephew, Inc.
71338960
In Commercial Distribution

  • 00885556020685 ()
71338960

  • Ceramic acetabular liner

R3 ACETABULAR - 00885556020661

R3 32MM ID US CERAMIC ACET LINER MM50
Smith & Nephew, Inc.
71338950
In Commercial Distribution

  • 00885556020661 ()
71338950

  • Ceramic acetabular liner

REFLECTION - 00885556020494

ALUMINA CERAMIC LINER 28ID 46-48OD
Smith & Nephew, Inc.
71338346
Not in Commercial Distribution

  • 00885556020494 ()
71338346

  • Ceramic acetabular liner

NA - 00885556020340

ACETABULAR LINER 26MM Inner Diameter 46-48MM Outer Diameter 0 DEGREE
Smith & Nephew, Inc.
71340646
In Commercial Distribution

  • 00885556020340 ()
71340646

  • Ceramic acetabular liner

REFLECTION - 00885556020104

REFLECTION XLPE 22 0 DEG LATERALIZED +4 42 B ETO
Smith & Nephew, Inc.
71334551
In Commercial Distribution

  • 00885556020104 ()
71334551

  • Ceramic acetabular liner

SeraQuest - 00850487007333

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)

ReQuest - 00850487007142

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)

Trinity Biotech - 05391516746496

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)

AtheNA Multi-Lyte® HSV-1 & 2 IgG Plus Test System - 00845533000055

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

Alinity - 00380740193805

AdviseDx SARS-CoV-2 IgG II Calibrator Kit
Abbott Ireland Diagnostics
06S6101
In Commercial Distribution

  • 00380740193805 ()
06S6101

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator

ARCHITECT - 00380740193720

AdviseDx SARS-CoV-2 IgG II Calibrator Kit
Abbott Ireland Diagnostics
06S6001
In Commercial Distribution

  • 00380740193720 ()
06S6001

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator

Alinity - 00380740192105

SARS-CoV-2 IgG Calibrator Kit
ABBOTT LABORATORIES
06R9001
In Commercial Distribution

  • 00380740192105 ()
06R9001

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator

ARCHITECT - 00380740191818

SARS-CoV-2 IgG Calibrator Kit
ABBOTT LABORATORIES
06R8601
In Commercial Distribution

  • 00380740191818 ()
06R8601

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator

ImmunoFA Toxoplasma IgG Conjugate - 00613745012025

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

BioPlex 2200 - 00847865010993

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

Bio-Rad Laboratories, Inc. - 00847865010740

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)

BioPlex 2200 - 00847865004725

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

BioPlex 2200 - 00847865002479

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

BioPlex 2200 - 00847865002172

Manual & CDs, HSV-1 & HSV-2 IgG IFU, SW4.1_v2
BIO-RAD LABORATORIES, INC.
SW4.1_V2
In Commercial Distribution

  • 00847865002172 ()

  • 1 Each
6653360F

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

BioPlex 2200 - 00847865000949

HSV-1 & HSV-2 Reagent Pack
BIO-RAD LABORATORIES, INC.
6653350
In Commercial Distribution

  • 00847865000949 ()

  • 100 Tests
6653350

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

BioPlex 2200 - 00847865000918

HSV-1 & HSV-2 IgG Calibrator Lot Data
BIO-RAD LABORATORIES, INC.
6633320
In Commercial Distribution

  • 00847865000918 ()

  • 1 Each
6633320

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

BioPlex 2200 - 00847865000901

HSV-1 & HSV-2 IgG Calibrator Set
BIO-RAD LABORATORIES, INC.
6633300
In Commercial Distribution

  • 00847865000901 ()

  • 4 Vials
  • Total Volume: 0.5 Milliliter
6633300

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

DV/DM COV2G/CV2G CAL - 00630414607047

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

IMMULITE® / IMMULITE® 1000 Systems HER Herpes I and II IgG - 00630414964171

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 - 00630414999784

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

VITROS - 10758750033614

VITROS Immunodiagnostic Products Anti-SARS-COV-2 IgG Calibrator
ORTHO CLINICAL DIAGNOSTICS
6199952
In Commercial Distribution

  • 20758750033611 ()
  • 10758750033614 ()
6199952

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator

HSV-1 and HSV-2 Immunoblot IgG Negative Control - 10816101021038

No Description
DIASORIN MOLECULAR LLC
IB0910
In Commercial Distribution

  • 10816101021038 ()
IB0910

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

HSV-1 and HSV-2 Immunoblot IgG Cutoff/Positive Control - 10816101021021

No Description
DIASORIN MOLECULAR LLC
IB0913
In Commercial Distribution

  • 10816101021021 ()
IB0913

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

HSV-2 IgG Antigen Wells - 10816101022370

No Description
DIASORIN MOLECULAR LLC
EL0902
In Commercial Distribution

  • 10816101022370 ()
EL0902

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, reagent

HSV-1 IgG Antigen Wells - 10816101022363

No Description
DIASORIN MOLECULAR LLC
EL0901
In Commercial Distribution

  • 10816101022363 ()
EL0901

  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, reagent

HSV-2 ELISA IgG Conjugate - 10816101022172

No Description
DIASORIN MOLECULAR LLC
EL0917
In Commercial Distribution

  • 10816101022172 ()
EL0917

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, reagent

HSV-1 ELISA IgG Conjugate - 10816101022165

No Description
DIASORIN MOLECULAR LLC
EL0916
In Commercial Distribution

  • 10816101022165 ()
EL0916

  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, reagent

Herpes Simplex Virus Type 2 / HSV-2 IgG IFA Slides Only Kit - G5229026011

For the detection and titration of HSV-2 IgG antibodies in human sera
Hemagen Diagnostics, Inc.
902601
In Commercial Distribution

  • G5229026011 ()


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

Herpes Simplex Virus Type 2 / HSV-2 IgG IFA 96 Test - G522902600

For the detection and titration of HSV-2 IgG antibodies in human sera
Hemagen Diagnostics, Inc.
902600
In Commercial Distribution

  • G522902600 ()


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

Elecsys HSV-2 IgG - 04015630940448

No Description
Roche Diagnostics GmbH
07027508190
In Commercial Distribution

  • 04015630940448 ()
07027508190

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

Elecsys HSV-1 IgG - 04015630940431

No Description
Roche Diagnostics GmbH
07027494190
In Commercial Distribution

  • 04015630940431 ()
07027494190

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

Elecsys HSV2 IgG Immunoassay - 04015630939053

No Description
Roche Diagnostics GmbH
5572193160
In Commercial Distribution

  • 04015630939053 ()
5572193160

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