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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Trinity Biotech - 05391516746243

B. burgdorferi (IgM) Marblot Strip Test System (50 Tests)
MARDX DIAGNOSTICS, INC.
40-5065M
In Commercial Distribution

  • 05391516746243 ()
40-5065M

  • Borrelia burgdorferi immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Trinity Biotech - 05391516746212

B. burgdorferi (IgM) Marblot Strip Test System (20 Tests)
MARDX DIAGNOSTICS, INC.
40-2075M
In Commercial Distribution

  • 05391516746212 ()
40-2075M

  • Borrelia burgdorferi immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Trinity Biotech - 05391516745048

CAPTIA™ NMT Syphilis IgM
CLARK LABORATORIES, INC.
2329360
In Commercial Distribution

  • 05391516745048 ()

  • 96 Tests
2329360

  • Treponema pallidum immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

PLATELIA - 03610520007860

PLATELIA Lyme IgM
BIO-RAD
25296
Not in Commercial Distribution

  • 03610520007860 ()
25296

  • Borrelia burgdorferi immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Anti-Borrelia burgdorferi US EUROLINE-WB (IgM) - 04049016134992

No Description
EUROIMMUN Medizinische Labordiagnostika AG
DY 2133-24001-1 M
In Commercial Distribution

  • 04049016134992 ()


  • Borrelia burgdorferi immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Anti-Borrelia burgdorferi US EUROLINE-WB (IgM) - 04049016134985

No Description
EUROIMMUN Medizinische Labordiagnostika AG
DY 2133-3001-1 M
In Commercial Distribution

  • 04049016134985 ()


  • Borrelia burgdorferi immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Anti-Bordetella pertussis ELISA (IgM) - 04049016096047

No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2050-9601 M
Not in Commercial Distribution

  • 04049016096047 ()


  • Bordetella pertussis immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

VIDAS® Lyme IgM II - 03573026447151

VIDAS Lyme IgM II assay is an automated qualitative enzyme immunoassay intended for use on VIDAS family instrument for detection of human IgM antibodies to Borrelia burgdorferi.
BIOMERIEUX SA
416436
In Commercial Distribution

  • 03573026447151 ()


  • Borrelia burgdorferi immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

ELISA B. burgdorferi IgM Smart Kit Test System - 00845533000208

The ZEUS ELISA Borrelia burgdorferi IgM Test System is an enzyme-linked immunosorbent assay (ELISA) for the qualitative presumptive detection of IgM antibodies to Borrelia burgdorferi in human sera. This Test System 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.
SM3Z9651M
In Commercial Distribution

  • 00845533000208 ()
SM3Z9651M

  • Borrelia burgdorferi immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

ELISA B. burgdorferi IgM Test System - 00845533000192

The ZEUS ELISA Borrelia burgdorferi IgM Test System is an enzyme-linked immunosorbent assay (ELISA) for the qualitative presumptive detection of IgM antibodies to Borrelia burgdorferi in human sera. This Test System 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.
3Z9651M
In Commercial Distribution

  • 00845533000192 ()
3Z9651M

  • Borrelia burgdorferi immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

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

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

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

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

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

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

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
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