SEARCH RESULTS FOR: 男M♥飞机号@zykaifa中国云南省普洱市墨江哈尼族自治县(41984 results)

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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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JAS Diagnostics - 00817274021774

HEMOGLOBIN A1C REAGENT, (2x 30mL R1, 2x 9.5mL R2a, 2x 0.5mL R2b)
DREW SCIENTIFIC, INC.
XL-A1C2-30
In Commercial Distribution

  • 00817274021774 ()


  • Cryptosporidium parvum immunoglobulin A (IgA)/IgG/IgM antibody IVD, reagent

JAS Diagnostics - 00817274021767

HEMOGLOBIN A1C REAGENT, (2x 30mL R1, 2x 9.5mL R2a, 2x 0.5mL R2b)
DREW SCIENTIFIC, INC.
A1C2-30
In Commercial Distribution

  • 00817274021767 ()


  • Cryptosporidium parvum immunoglobulin A (IgA)/IgG/IgM antibody IVD, reagent

JAS Diagnostics - 00817274021750

HEMOGLOBIN A1C REAGENT (1x 30mL R1, 1x 9.5mL R2a, 1x 0.5mL R2b
DREW SCIENTIFIC, INC.
A1C2-30A
In Commercial Distribution

  • 00817274021750 ()


  • Cryptosporidium parvum immunoglobulin A (IgA)/IgG/IgM antibody IVD, reagent

EL-Anti-SARS-CoV-2 IgM - 00854473003323

ANTI-SARS-CoV-2 IgM ANTIBODY ELISA TEST KIT, 96 TESTS
THERA-TEST LABORATORIES, INC
104-129
Not in Commercial Distribution

  • 00854473003323 ()
104-129

  • SARS-CoV-2 immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Serodia TP-PA - 00850212007027

220 test kit
FUJIREBIO DIAGNOSTICS, INC.
1633
In Commercial Distribution

  • 00850212007027 ()

  • Size Type = Tests per Kit; Size Unit = 220; Unit of Measure = Tests


  • Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, agglutination

Serodia TP-PA - 00850212007010

100 test kit
FUJIREBIO DIAGNOSTICS, INC.
1626
In Commercial Distribution

  • 00850212007010 ()

  • Size Type = Tests per Kit; Size Unit = 100; Unit of Measure = Tests


  • Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, agglutination

Serodia TP-PA Kits - 00869164000062

220 test kits
FUJIREBIO DIAGNOSTICS, INC.
234976
In Commercial Distribution

  • 00869164000062 ()

  • 220 tests per kit


  • Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, agglutination

Serodia TP-PA Kits - 00869164000055

100 test kit
FUJIREBIO DIAGNOSTICS, INC.
234952
In Commercial Distribution

  • 00869164000055 ()

  • 100 tests per kit


  • Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, agglutination

PK7400 TP HA REAGENT - 05060515140030

PK7400 TP HA REAGENT is a hemagglutination assay intended for the qualitative screening of blood and plasma donors for the detection of Treponema pallidum IgG and IgM antibodies to syphilis in human serum, EDTA plasma or CPDA plasma using the Beckman Coulter PK7400 Automated Microplate System. This assay is not intended for diagnostic use.
NEWMARKET BIOMEDICAL LIMITED
B11186
In Commercial Distribution

  • 05060515140030 ()

  • 3600 tests


  • Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, agglutination

ARCHITECT - 00380740192167

AdviseDx SARS-CoV-2 IgM Reagent Kit 500 Test
Abbott Ireland Diagnostics
06R8730
In Commercial Distribution

  • 00380740192167 ()
06R8730

  • SARS-CoV-2 immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

Alinity - 00380740192099

AdviseDx SARS-CoV-2 IgM Reagent Kit 1000 Test
Abbott Ireland Diagnostics
06R9130
In Commercial Distribution

  • 00380740192099 ()
06R9130

  • SARS-CoV-2 immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

Alinity - 00380740192082

AdviseDx SARS-CoV-2 IgM Reagent Kit 200 Test
Abbott Ireland Diagnostics
06R9120
In Commercial Distribution

  • 00380740192082 ()
06R9120

  • SARS-CoV-2 immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

ARCHITECT - 00380740191863

AdviseDx SARS-CoV-2 IgM Reagent Kit 100 Test
Abbott Ireland Diagnostics
06R8720
In Commercial Distribution

  • 00380740191863 ()
06R8720

  • SARS-CoV-2 immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

Lumipulse G TP-N Immunoreaction Cartridges Set - 04987270235041

No Description
FUJIREBIO INC.
235041
In Commercial Distribution

  • 04987270235041 ()

  • Size Type = Units per kit; Units = 2; Unit of Measure = 2mL
  • Size Type =Tests Per Kit; Size Unit = 42; Unit of Measure = Tests


  • Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, chemiluminescent immunoassay

Beckman Coulter PK TP System - 04987270226964

No Description
FUJIREBIO INC.
226964
In Commercial Distribution

  • 04987270226964 ()

  • Size Type = Tests Per Kit; Size Unit = 3000; Unit of Measure = Tests
PH3000

  • Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, agglutination

SCoV-2 Detect™ IgM ELISA - B379COVEM1

No Description
INBIOS INTERNATIONAL, INC
COVE-M
In Commercial Distribution

  • B379COVEM1 ()


  • SARS-CoV-2 immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Gold Standard Diagnostics SARS-CoV-2 IgM ELISA Test Kit - B350GSD0110300

Gold Standard Diagnostics SARS-CoV-2 IgM ELISA Test Kit for the qualitative detection of IgM antibodies to SARS-CoV-2 virus to aid in the diagnosis of Coronavirus (COVID-19).
Gold Standard Diagnostics Corporation
GSD01-1030
Not in Commercial Distribution

  • B350GSD0110300 ()
GSD01-1030

  • SARS-CoV-2 immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

SARS-CoV-2 IgM AccuBind ELISA Test System - 192 Wells - 00816870023649

No Description
MONOBIND, INC.
11725-300
In Commercial Distribution

  • 00816870023649 ()

  • Width: 7.75 Inch
11725-300B

  • SARS-CoV-2 immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

SARS-CoV-2 IgM AccuBind ELISA Test System - 96 Wells - 00816870023632

No Description
MONOBIND, INC.
11725-300
In Commercial Distribution

  • 00816870023632 ()

  • Width: 7.75 Inch
11725-300A

  • SARS-CoV-2 immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Access SARS-CoV-2 IgM - 15099590738617

The Access SARS-CoV-2 IgM is a paramagnetic particle, chemiluminescent immunoassay intended for the qualitative detection of IgM antibodies to SARS-CoV-2 in human serum, serum separator tubes and plasma (lithium heparin, dipotassium EDTA, tripotassium EDTA, sodium citrate). The Access SARS-CoV-2 IgM is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The Access SARS-CoV-2 IgM should not be used to diagnose acute SARS-CoV-2 infection. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet requirements to perform moderate or high complexity tests. The Access SARS-CoV-2 IgM assay is only for use under the Food and Drug Administration's Emergency Use Authorization.
Beckman Coulter, Inc.
C58957
In Commercial Distribution

  • 15099590738617 ()
C58957

  • SARS-CoV-2 immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

SeraQuest - 00850487007418

Epstein-Barr virus (EBV) VCA immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
EB VCA M
In Commercial Distribution

  • 00850487007418 ()
Q01-480

  • Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

ReQuest - 00850487007173

Epstein-Barr virus (EBV) VCA immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
EB VCA M
In Commercial Distribution

  • 00850487007173 ()
Q01-480

  • Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Trinity Biotech - 05391516747707

Alkaline Phosphatase Developing Solution, 110mL
MARDX DIAGNOSTICS, INC.
44-5017
In Commercial Distribution

  • 05391516747707 ()
44-5017

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)

Trinity Biotech - 05391516747653

10x Sample Diluent/Wash Solution, 100 mL
MARDX DIAGNOSTICS, INC.
40-2019C
In Commercial Distribution

  • 05391516747653 ()
40-2019C

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)

Trinity Biotech - 05391516747486

Captia Borrelia burgdorferi IgG/IgM
CLARK LABORATORIES, INC.
2346581
In Commercial Distribution

  • 05391516747486 ()

  • 480 Tests
2346581

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)

Platelia - 05391516747196

EBV IgG/IgM Concentrated Washing Solution (20x)
CLARK LABORATORIES, INC.
827102
In Commercial Distribution

  • 05391516747196 ()

  • Total Volume: 50 Milliliter
827102

  • Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Trinity Biotech - 05391516747189

Captia™ Borrelia burgdorferi IgG/IgM
CLARK LABORATORIES, INC.
2346580
In Commercial Distribution

  • 05391516747189 ()

  • 96 tests
2346580

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)

Trinity Biotech - 05391516747103

Captia™ EBNA-1 IgM
CLARK LABORATORIES, INC.
2325861
In Commercial Distribution

  • 05391516747103 ()

  • 480 Tests
2325861

  • Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Trinity Biotech - 05391516747080

Captia™ EBV VCA IgM
CLARK LABORATORIES, INC.
2325761
In Commercial Distribution

  • 05391516747080 ()

  • 480 Tests
2325761

  • Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

MarDx - 05391516746618

Borrelia burgdorferi EIA IgG + IgM
CLARK LABORATORIES, INC.
40-8696P/J
In Commercial Distribution

  • 05391516746618 ()

  • 480 Tests
40-8696P/J

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)

MarDx - 05391516746601

Borrelia burgdorferi EIA IgG + IgM
CLARK LABORATORIES, INC.
40-8696P
In Commercial Distribution

  • 05391516746601 ()

  • 96 Tests
40-8696P

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)

Bio-Rad Platelia - 05391516746540

EBV-VCA IgM
CLARK LABORATORIES, INC.
72936
In Commercial Distribution

  • 05391516746540 ()
72936

  • Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Trinity Biotech - 05391516746397

FTA-ABS, 10 Well Slides, 10 each pack
MARDX DIAGNOSTICS, INC.
31-8010
In Commercial Distribution

  • 05391516746397 ()
31-8010

  • Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)

Trinity Biotech - 05391516746304

B. burgdorferi EIA (IgG, IgM) Test System (480 Tests)
MARDX DIAGNOSTICS, INC.
40-8696P/J
In Commercial Distribution

  • 05391516746304 ()
40-8696P/J

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)

Trinity Biotech - 05391516746298

B. burgdorferi EIA (IgG, IgM) Test System (96 Tests)
MARDX DIAGNOSTICS, INC.
40-8696P
In Commercial Distribution

  • 05391516746298 ()
40-8696P

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)

Trinity Biotech - 05391516743587

Captia™ EBNA-1 IgM
CLARK LABORATORIES, INC.
2325860
In Commercial Distribution

  • 05391516743587 ()

  • 96 Tests
2325860

  • Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Trinity Biotech - 05391516743556

Captia™ EBV VCA IgM
CLARK LABORATORIES, INC.
2325760
In Commercial Distribution

  • 05391516743556 ()

  • 96 Tests
2325760

  • Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

QMedix™ - 00850054026378

QMedix™ Lyme IgG/IgM ELISA This test is intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to Borrelia burgdorferi in a clinical specimen, using an enzyme immunoassay (EIA) method.
Diagnostic Automation, Inc.
DACD1423-55
In Commercial Distribution

  • 00850054026378 ()

  • 96 Tests
1423-55

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)

C6 B. burgdorferi (Lyme) ELISA - 00863782000305

No Description
IMMUNETICS, INC.
DK-E352-096
In Commercial Distribution

  • 00863782000305 ()


  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)

ELISA Borrelia VlsE1/pepC10 IgG/IgM Q Test System - 00845533000260

The ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System is intended for the qualitative detection of IgG and IgM class antibodies to VlsE1 and pepC10 antigens from Borrelia burgdorferi in human serum. The assay is intended for testing serum samples from symptomatic patients or those with a history of Lyme Borreliosis. All positive and equivocal specimens should be tested with a second-tier test such as Western Blot, which if positive, is supportive evidence of infection with Borrelia burgdorferi. Diagnosis of Lyme Borreliosis should be made based on the presence of B. burgdorferi antibodies, history, symptoms, and other laboratory data. Negative first or second tier results should not be used to exclude Borreliosis. This assay is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
Q3Z9661B
In Commercial Distribution

  • 00845533000260 ()
Q3Z9661B

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)

ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System - 00845533000246

The ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System is intended for the qualitative detection of IgG and IgM class antibodies to VlsE1 and pepC10 antigens from Borrelia burgdorferi in human serum. The assay is intended for testing serum samples from symptomatic patients or those with a history of Lyme Borreliosis. All positive and equivocal specimens should be tested with a second-tier test such as Western Blot, which if positive, is supportive evidence of infection with Borrelia burgdorferi. Diagnosis of Lyme Borreliosis should be made based on the presence of B. burgdorferi antibodies, history, symptoms, and other laboratory data. Negative first or second tier results should not be used to exclude Borreliosis. This assay is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
3Z9661
In Commercial Distribution

  • 00845533000246 ()
3Z9661

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)

ELISA B. burgdorferi IgG/IgM Bulk Test System - 00845533000222

The ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System is an enzyme-linked immunosorbent assay (ELISA) for the qualitative presumptive detection of total (IgG and IgM) antibodies to Borrelia burgdorferi in human serum. This ELISA should only be used for patients with signs and symptoms that are consistent with Lyme disease. Equivocal or positive results must be supplemented by testing with a standardized Western blot procedure. Positive supplemental results are supportive evidence of exposure to B. burgdorferi and can be used to support a clinical diagnosis of Lyme disease.
ZEUS SCIENTIFIC, INC.
3Z9651B
In Commercial Distribution

  • 00845533000222 ()
3Z9651B

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)

ELISA EBV-VCA IgM Smart Kit Test System - 00845533000512

The ZEUS ELISA Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgM Test System is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of IgM class antibodies to Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) in human sera. The Test System is intended to be used for the diagnosis of EBV-associated infectious mononucleosis when used in conjunction with other EBV serological assays. This test is for In Vitro diagnostic use only.
ZEUS SCIENTIFIC, INC.
SM9Z9201M
In Commercial Distribution

  • 00845533000512 ()
SM9Z9201M

  • Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

ELISA EBV-VCA IgM Q Test System - 00845533000505

The ZEUS ELISA Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgM Test System is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of IgM class antibodies to Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) in human sera. The Test System is intended to be used for the diagnosis of EBV-associated infectious mononucleosis when used in conjunction with other EBV serological assays. This test is for In Vitro diagnostic use only.
ZEUS SCIENTIFIC, INC.
Q9Z9201MB
In Commercial Distribution

  • 00845533000505 ()
Q9Z9201MB

  • Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

ELISA EBV-VCA IgM Test System - 00845533000499

The ZEUS ELISA Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgM Test System is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of IgM class antibodies to Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) in human sera. The Test System is intended to be used for the diagnosis of EBV-associated infectious mononucleosis when used in conjunction with other EBV serological assays. This test is for In Vitro diagnostic use only.
ZEUS SCIENTIFIC, INC.
9Z9201M
In Commercial Distribution

  • 00845533000499 ()
9Z9201M

  • Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

ELISA Borrelia VlsE1/pepC10 IgG/IgM Smart Kit Test System - 00845533000277

The ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System is intended for the qualitative detection of IgG and IgM class antibodies to VlsE1 and pepC10 antigens from Borrelia burgdorferi in human serum. The assay is intended for testing serum samples from symptomatic patients or those with a history of Lyme Borreliosis. All positive and equivocal specimens should be tested with a second-tier test such as Western Blot, which if positive, is supportive evidence of infection with Borrelia burgdorferi. Diagnosis of Lyme Borreliosis should be made based on the presence of B. burgdorferi antibodies, history, symptoms, and other laboratory data. Negative first or second tier results should not be used to exclude Borreliosis. This assay is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
SM3Z9661
In Commercial Distribution

  • 00845533000277 ()
SM3Z9661

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)

ELISA Borrelia VlsE1/pepC10 IgG/IgM Bulk Test System - 00845533000253

The ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System is intended for the qualitative detection of IgG and IgM class antibodies to VlsE1 and pepC10 antigens from Borrelia burgdorferi in human serum. The assay is intended for testing serum samples from symptomatic patients or those with a history of Lyme Borreliosis. All positive and equivocal specimens should be tested with a second-tier test such as Western Blot, which if positive, is supportive evidence of infection with Borrelia burgdorferi. Diagnosis of Lyme Borreliosis should be made based on the presence of B. burgdorferi antibodies, history, symptoms, and other laboratory data. Negative first or second tier results should not be used to exclude Borreliosis. This assay is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
3Z9661B
In Commercial Distribution

  • 00845533000253 ()
3Z9661B

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)

ELISA B. burgdorferi IgG/IgM Smart Kit Test System - 00845533000239

The ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System is an enzyme-linked immunosorbent assay (ELISA) for the qualitative presumptive detection of total (IgG and IgM) antibodies to Borrelia burgdorferi in human serum. This ELISA should only be used for patients with signs and symptoms that are consistent with Lyme disease. Equivocal or positive results must be supplemented by testing with a standardized Western blot procedure. Positive supplemental results are supportive evidence of exposure to B. burgdorferi and can be used to support a clinical diagnosis of Lyme disease.
ZEUS SCIENTIFIC, INC.
SM3Z9651
In Commercial Distribution

  • 00845533000239 ()
SM3Z9651

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)

ELISA B. burgdorferi IgG/IgM Test System - 00845533000215

The ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System is an enzyme-linked immunosorbent assay (ELISA) for the qualitative presumptive detection of total (IgG and IgM) antibodies to Borrelia burgdorferi in human serum. This ELISA should only be used for patients with signs and symptoms that are consistent with Lyme disease. Equivocal or positive results must be supplemented by testing with a standardized Western blot procedure. Positive supplemental results are supportive evidence of exposure to B. burgdorferi and can be used to support a clinical diagnosis of Lyme disease.
ZEUS SCIENTIFIC, INC.
3Z9651
In Commercial Distribution

  • 00845533000215 ()
3Z9651

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)

AtheNA Multi-Lyte® EBV-VCA IgM Plus Test System - 00845533000048

The ZEUS AtheNA Multi-Lyte® Epstein-Barr Virus - Viral Capsid Antigen (EBV-VCA) IgM Plus Test System is a microparticle-based immunoassay intended for the qualitative detection of IgM class antibody to the Epstein-Barr virus, viral capsid antigen in human serum using the AtheNA Multi-Lyte System. The test system is intended to be used for the laboratory diagnosis of EBV-associated infectious mononucleosis and provides epidemiological information on the diseases caused by Epstein-Barr virus. Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, neonatal specimens, or infants. Assay performance characteristics have not been established for the diagnosis of nasopharyngeal carcinoma, Burkitt's lymphoma, and other EBV-associated lymphomas. This test is for In Vitro diagnostic use only.
ZEUS SCIENTIFIC, INC.
A92101M
In Commercial Distribution

  • 00845533000048 ()
A92101M

  • Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
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