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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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

AccuDiag ™ - 00850049545259

AccuDiag™ Borrelia VlsE1pepC10 IgG/IgM ELISA A collection of reagents and other associated materials 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 method.
Diagnostic Automation, Inc.
DACD1427-2
In Commercial Distribution

  • 00850049545259 ()

  • 96 Tests
1427-2

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

ELISA Borrelia VlsE1/pepC10 IgG/IgM Smart Kit Test System - 00845533001854

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.
PF-SM3Z9661
In Commercial Distribution

  • 00845533001854 ()
PF-SM3Z9661

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

IFA EBV-VCA IgM Test System - 00845533001588

The ZEUS IFA Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgM Test System is a pre-standardized test system designed for the qualitative and semi-quantitative detection of EBV-VCA IgM antibodies in human serum by the indirect fluorescent antibody (IFA) technique, and is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
FA9151M
In Commercial Distribution

  • 00845533001588 ()
FA9151M

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

Tissue-Tek Genie® - 00615233002327

FITC anti-IgM Goat Polyclonal Antibody, 10 RTU capsules
SAKURA FINETEK U.S.A., INC.
8537-C010
In Commercial Distribution

  • 00615233002327 ()
8537-C010

  • Human immunoglobulin M (IgM) animal conjugate antibody reagent IVD

Bio-Rad Laboratories, Inc. - 00847865011495

Anti-Borrelia (Lyme) EIA, Conjugate
Bio-RAD Laboratories, Inc.
25274
In Commercial Distribution

  • 00847865011495 ()

  • Total Volume: 12 Milliliter
25274

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

Bio-Rad Laboratories, Inc. - 00847865011488

Anti-Borrelia (Lyme) EIA, Borrelia Blocker
Bio-RAD Laboratories, Inc.
25272
In Commercial Distribution

  • 00847865011488 ()

  • Total Volume: 25 Milliliter
25272

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

Bio-Rad Laboratories, Inc. - 00847865011471

Anti-Borrelia (Lyme) EIA, Positive Control
Bio-RAD Laboratories, Inc.
25271
In Commercial Distribution

  • 00847865011471 ()

  • Total Volume: 0.1 Milliliter
25271

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

Bio-Rad Laboratories, Inc. - 00847865011464

Anti-Borrelia (Lyme) EIA, Negative Control
Bio-RAD Laboratories, Inc.
25270
In Commercial Distribution

  • 00847865011464 ()

  • Total Volume: 0.3 Milliliter
25270

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

Bio-Rad Laboratories, Inc. - 00847865011457

Anti-Borrelia (Lyme) EIA Calibrator
Bio-RAD Laboratories, Inc.
25269
In Commercial Distribution

  • 00847865011457 ()

  • Total Volume: 0.3 Milliliter
25269

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

BioPlex 2200 - 00847865011358

Manual & CDs, EBV IgM IFU, SW4_v2
BIO-RAD LABORATORIES, INC.
SW4V2
In Commercial Distribution

  • 00847865011358 ()

  • 1 Each
6651360F

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