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

  • 00380740192105 ()
06R9001

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator
SARS-CoV-2 IgG Calibrator Kit
ABBOTT LABORATORIES
06R8601
In Commercial Distribution

  • 00380740191818 ()
06R8601

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator
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
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
No Description
DIASORIN MOLECULAR LLC
IB0900G
In Commercial Distribution

  • 20816101021004 ()
IB0900G

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, immunoblot
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
The Access SARS-CoV-2 IgG II Calibrators are intended to calibrate the Access SARS-CoV-2 IgG II assay for the in vitro semi-quantitative and qualitative detection of SARS-CoV-2 IgG antibodies in human plasma (lithium heparin, dipotassium EDTA, tripotassium EDTA, and sodium citrate) for use on the Access Immunoassay Systems only. The Access SARS-CoV-2 IgG II calibrators are only for use under the Food and Drug Administration's Emergency Use Authorization.
Beckman Coulter, Inc.
C69058
In Commercial Distribution

  • 15099590742751 ()
C69058

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator
The Access SARS-CoV-2 IgG Calibrators are intended to calibrate the Access SARS-CoV-2 IgG assay for the in vitro qualitative detection of SARS-CoV-2 IgG antibodies in human serum, serum separator tubes and plasma (lithium heparin, dipotassium EDTA, tripotassium EDTA, and sodium citrate) for use on the Access Family of Immunoassay Systems only. The Access SARS-CoV-2 IgG Calibrators are only for use under the Food and Drug Administration's Emergency Use Authorization.
Beckman Coulter, Inc.
C58963
In Commercial Distribution

  • 15099590738655 ()
C58963

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator
No Description
IMMUNODIAGNOSTIC SYSTEMS LIMITED
IS-ID6530
In Commercial Distribution

  • 05060169695979 ()


  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, control
Captia™ Chlamydia IgG
CLARK LABORATORIES, INC.
2346200
In Commercial Distribution

  • 05391516743952 ()

  • 96 Tests
2346200

  • Multiple Chlamydia species immunoglobulin G (IgG) antibody IVD, reagent
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