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
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 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
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)
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
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
No Description
Roche Diagnostics GmbH
08948887160
In Commercial Distribution

  • 07613336170694 ()
08948887160

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
08948909190
In Commercial Distribution

  • 07613336170687 ()
08948909190

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
08948844160
In Commercial Distribution

  • 07613336170663 ()
08948844160

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
08948852190
In Commercial Distribution

  • 07613336170656 ()
08948852190

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
Pointe Scientific, Inc. HSV-1 & 2 IgG Reagent is for the qualitative, and semi-quantitative detection of human IgG antibodies to type 1 and type 2 herpes simplex virus (HSV) in human serum by enzyme immunoassay. To aid in the evaluation of the patient's immunological history with HSV, including women of childbearing age. These reagents have not received FDA clearance for use in testing blood or plasma donors. 96 tests.
POINTE SCIENTIFIC, INC.
T8007-96
In Commercial Distribution

  • 00811727015211 ()
T8007-96

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
HBcAg antibody is the purified immunoglobulin fraction of rabbit antiserum, diluted in phosphate buffered saline, pH 7.6
BIO SB, INC.
Concentrate, 1 ml
In Commercial Distribution

  • B502BSB56150 ()
BSB 5615

  • Hepatitis B virus core immunoglobulin G (IgG) antibody IVD, reagent
HBcAg antibody is the purified immunoglobulin fraction of rabbit antiserum, diluted in phosphate buffered saline, pH 7.6
BIO SB, INC.
Concentrate, 0.5 ml
In Commercial Distribution

  • B502BSB56140 ()
BSB 5614

  • Hepatitis B virus core immunoglobulin G (IgG) antibody IVD, reagent
HBcAg antibody is the purified immunoglobulin fraction of rabbit antiserum, diluted in phosphate buffered saline, pH 7.6
BIO SB, INC.
Concentrate, 0.1 ml
In Commercial Distribution

  • B502BSB56130 ()
BSB 5613

  • Hepatitis B virus core immunoglobulin G (IgG) antibody IVD, reagent
Tinto Hepatitis B Virus Core Antigen (HBcAg) antibody is the purified immunoglobulin fraction of rabbit antiserum, diluted in phosphate buffered saline, pH 7.6
BIO SB, INC.
Predilute, 15 ml
In Commercial Distribution

  • B502BSB56120 ()
BSB 5612

  • Hepatitis B virus core immunoglobulin G (IgG) antibody IVD, reagent
Tinto Hepatitis B Virus Core Antigen (HBcAg) antibody is the purified immunoglobulin fraction of rabbit antiserum, diluted in phosphate buffered saline, pH 7.6
BIO SB, INC.
Predilute, 7 ml
In Commercial Distribution

  • B502BSB56110 ()
BSB 5611

  • Hepatitis B virus core immunoglobulin G (IgG) antibody IVD, reagent
Tinto Hepatitis B Virus Core Antigen (HBcAg) antibody is the purified immunoglobulin fraction of rabbit antiserum, diluted in phosphate buffered saline, pH 7.6
BIO SB, INC.
Predilute, 3 ml
In Commercial Distribution

  • B502BSB56100 ()
BSB 5610

  • Hepatitis B virus core immunoglobulin G (IgG) antibody IVD, reagent
No Description
MONOBIND, INC.
6725-300
In Commercial Distribution

  • 00816870024332 ()

  • Width: 7.75 Inch
6725-300B

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Detection of Herpes Simplex 1 and 2 Antibodies
ARLINGTON SCIENTIFIC, INC.
NC-830096-AG
In Commercial Distribution

  • 00816057020577 ()

  • 96 Test
NC-830096-AG

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
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
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
No Description
DIASORIN MOLECULAR LLC
EL0902
In Commercial Distribution

  • 10816101022370 ()
EL0902

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, reagent
No Description
DIASORIN MOLECULAR LLC
EL0901
In Commercial Distribution

  • 10816101022363 ()
EL0901

  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, reagent
No Description
DIASORIN MOLECULAR LLC
EL0916
In Commercial Distribution

  • 10816101022165 ()
EL0916

  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, reagent
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
No Description
DIASORIN MOLECULAR LLC
EL0917
In Commercial Distribution

  • 10816101022172 ()
EL0917

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, reagent
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
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
No Description
Roche Diagnostics GmbH
5572185160
In Commercial Distribution

  • 04015630939046 ()
5572185160

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
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
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
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
ImmunoSimplicity (Is) HSV 1&2 IgG Test for the detection of IgG antibodies to herpes simplex virus (HSV) type 1 and/or type 2 as an aid in the diagnosis of a primary or reactivated infection with HSV.
Gold Standard Diagnostics Corporation
720-340
In Commercial Distribution

  • B3507203400 ()
720-340

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