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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For the detection of effector t cells that respond to stimulation by mycobacterium tuberculosis antigens esat-6 and cfp-10 and indicated for use as an aid in the diagnosis of m.Tuberculosis infection in conjunction with risk assesment, radiography and other medical diagnostic evaluations.
Oxford Immunotec, Inc.
TB.300
In Commercial Distribution

  • 15051716000305 ()
TB.300US

  • Mycobacterium tuberculosis complex species antigen IVD, kit, enzyme immunoassay (EIA)
For the detection of effector t cells that respond to stimulation by mycobacterium tuberculosis antigens esat-6 and cfp-10 and indicated for use as an aid in the diagnosis of M.Tuberculosis infection in conjunction with risk assessment, radiography and other medical diagnostic evaluations.
Oxford Immunotec, Inc.
TB.50
In Commercial Distribution

  • 15051716000046 ()
TB.50US

  • Mycobacterium tuberculosis complex species antigen IVD, kit, enzyme immunoassay (EIA)
For the detection of effector t cells that respond to stimulation by mycobacterium tuberculosis antigens esat-6 and cfp-10 and indicated for use as an aid in the diagnosis of m.Tuberculosis infection in conjunction with risk assesment, radiography and other medical diagnostic evaluations.
Oxford Immunotec, Inc.
TB.200
In Commercial Distribution

  • 15051716000008 ()
TB.200US

  • Mycobacterium tuberculosis complex species antigen IVD, kit, enzyme immunoassay (EIA)
Xpert MTB/RIF kit; 10 test kit
CEPHEID
GXMTB/RIF-US-10
In Commercial Distribution

  • 07332940000912 ()
GXMTB/RIF-US-10

  • MDR-TB/XDR-TB nucleic acid IVD, kit, nucleic acid technique (NAT)
IBP interface cable/锦江/Medex/LP4-40B/4.0M
Unimed Medical Supplies, Inc.
BC-JJ-MX
In Commercial Distribution

  • 06945664869195 ()


  • Electrical-only medical device connection cable, reusable
IBP interface cable/锦江/Argon/LP4-40B/4.0M
Unimed Medical Supplies, Inc.
BC-JJ-AG
In Commercial Distribution

  • 06945664869188 ()


  • Electrical-only medical device connection cable, reusable
No Description
HONSUN (NANTONG) CO.,LTD
HS-70A
In Commercial Distribution

  • 00697038425259 ()


  • Aneroid manual sphygmomanometer
No Description
HONSUN (NANTONG) CO.,LTD
HS-20A
In Commercial Distribution

  • 00697038425228 ()


  • Aneroid manual sphygmomanometer
No Description
HONSUN (NANTONG) CO.,LTD
HS-60A
In Commercial Distribution

  • 00697038425181 ()


  • Aneroid manual sphygmomanometer
No Description
HONSUN (NANTONG) CO.,LTD
HS-20
In Commercial Distribution

  • 00697038425143 ()


  • Aneroid manual sphygmomanometer
No Description
HONSUN (NANTONG) CO.,LTD
HS-70D
In Commercial Distribution

  • 00697038425266 ()


  • Aneroid manual sphygmomanometer
No Description
HONSUN (NANTONG) CO.,LTD
HS-70B
In Commercial Distribution

  • 00697038425198 ()


  • Aneroid manual sphygmomanometer
No Description
HONSUN (NANTONG) CO.,LTD
HS-201K1
In Commercial Distribution

  • 00697038425167 ()


  • Aneroid manual sphygmomanometer
No Description
HONSUN (NANTONG) CO.,LTD
HS-70D
In Commercial Distribution

  • 10697038425263 ()


  • Aneroid manual sphygmomanometer
No Description
HONSUN (NANTONG) CO.,LTD
HS-70A
In Commercial Distribution

  • 10697038425256 ()


  • Aneroid manual sphygmomanometer
No Description
HONSUN (NANTONG) CO.,LTD
HS-20A
In Commercial Distribution

  • 10697038425225 ()
  • 00697038425228 ()


  • Aneroid manual sphygmomanometer
No Description
HONSUN (NANTONG) CO.,LTD
HS-60A
In Commercial Distribution

  • 10697038425188 ()
  • 00697038425181 ()


  • Aneroid manual sphygmomanometer
No Description
HONSUN (NANTONG) CO.,LTD
HS-201K1
In Commercial Distribution

  • 10697038425164 ()
  • 00697038425167 ()


  • Aneroid manual sphygmomanometer
No Description
HONSUN (NANTONG) CO.,LTD
HS-20A
In Commercial Distribution

  • 10697038425140 ()
  • 00697038425143 ()


  • Aneroid manual sphygmomanometer
Intended use The Dermatophyte and C. albicans Real Time PCR Kit is an in vitro diagnostic kit for the quantitative detection of general dermatophytes (pan-dermatophytes), Trichophyton (T.) rubrum and Candida (C.) albicans in nail, skin, and hair specimens.
Ssi Diagnostica A/S
99462
In Commercial Distribution

  • 05713106994627 ()
99462

  • Multiple dermatophyte species nucleic acid IVD, kit, nucleic acid technique (NAT)
IBP interface cable/华南医电/Edwards/LP5/4.0M
Unimed Medical Supplies, Inc.
BC-HY-ED
In Commercial Distribution

  • 06945664869171 ()


  • Electrical-only medical device connection cable, reusable
U.S. IFU, Manual & CDs, BioPlex 2200 ToRC IgM IFU SW4.3_v1
BIO-RAD LABORATORIES, INC.
4.3_v1
In Commercial Distribution

  • 03610521167488 ()

  • 1 Each
12005791

  • Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
  • Rubella virus immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
  • Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
BioPlex 2200 ToRC IgM Control Set
BIO-RAD LABORATORIES, INC.
12000678
In Commercial Distribution

  • 03610520992753 ()

  • Total Volume: 1.5 Milliliter
  • 4 Vials
12000678

  • Rubella virus immunoglobulin M (IgM) antibody IVD, control
  • Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, control
  • Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, control
BioPlex 2200 ToRC IgM Reagent Pack
BIO-RAD LABORATORIES, INC.
12000670
In Commercial Distribution

  • 03610520992715 ()

  • 150 Tests
12000670

  • Rubella virus immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
  • Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
  • Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
BioPlex 2200 ToRC IgM Control Lot Data
BIO-RAD LABORATORIES, INC.
12000673
In Commercial Distribution

  • 03610520269541 ()

  • 1 Each
12000673

  • Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, control
  • Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, control
  • Rubella virus immunoglobulin M (IgM) antibody IVD, control
BioPlex 2200 ToRC IgM Assay Protocol File CD SW4.3_v1
BIO-RAD LABORATORIES, INC.
4.3_v1
In Commercial Distribution

  • 03610520150269 ()

  • 1 Each
12000671

  • Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
  • Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
  • Rubella virus immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
PRECISION CUT SHEAR 7-1/2 IN BLACK
D-M-S HOLDINGS, INC.
27-755-020
In Commercial Distribution

  • 10767056755021 ()
  • 00767056755024 ()


  • Bandage scissors, reusable
Stainless Steel Stethoscope, Adult - Black
D-M-S HOLDINGS, INC.
10-404-010
In Commercial Distribution

  • 10767056404028 ()
  • 00767056404021 ()


  • Mechanical external stethoscope
BioPlex 2200 ToRC IgM Calibrator Set
BIO-RAD LABORATORIES, INC.
12000677
In Commercial Distribution

  • 03610520992746 ()

  • Total Volume: 0.5 Milliliter
  • 2 Vials
12000677

  • Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, calibrator
  • Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, calibrator
  • Rubella virus immunoglobulin M (IgM) antibody IVD, calibrator
BioPlex 2200 ToRC IgM Calibrator Lot Data
BIO-RAD LABORATORIES, INC.
12000672
In Commercial Distribution

  • 03610520269534 ()

  • 1 Each
12000672

  • Rubella virus immunoglobulin M (IgM) antibody IVD, calibrator
  • Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, calibrator
  • Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, calibrator
Manual & CDs, Rubella & CMV IgM IFU, SW4.1_v1, U.S Only
BIO-RAD LABORATORIES, INC.
SW4.1_V1
Not in Commercial Distribution

  • 00847865012577 ()

  • 1 Each
6653860D

  • Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
  • Rubella virus immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
Rubella & CMV IgM Assay Protocol File CD, SW4.1_v1
BIO-RAD LABORATORIES, INC.
SW4.1_V1
Not in Commercial Distribution

  • 00847865011006 ()

  • 1 Each
6653870D

  • Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
  • Rubella virus immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
Rubella & CMV Assay Protocol File CD, SW4_v3
BIO-RAD LABORATORIES, INC.
SW4_ V3
Not in Commercial Distribution

  • 00847865003186 ()

  • 1 Each
6653870C

  • Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
  • Rubella virus immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
Manual & CDs, Rubella & CMV IgM IFU, SW4_v3, US Only
BIO-RAD LABORATORIES, INC.
SW4_V3
Not in Commercial Distribution

  • 00847865003179 ()

  • 1 Each
6653860C

  • Rubella virus immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
  • Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
Rubella & CMV IgM Reagent Pack
BIO-RAD LABORATORIES, INC.
6653850
Not in Commercial Distribution

  • 00847865001175 ()

  • 100 Tests
6653850

  • Rubella virus immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
  • Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
300-331A CMV IgM Capture Lyoph. Ag. Accessory Kit
DIAMEDIX CORPORATION
300-331A
In Commercial Distribution

  • 00817273020037 ()


  • Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
  • Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
Rubella & CMV Calibrator Lot Data
BIO-RAD LABORATORIES, INC.
6633820
Not in Commercial Distribution

  • 00847865001144 ()

  • 1 Each
6633820

  • Rubella virus immunoglobulin M (IgM) antibody IVD, reagent
  • Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, calibrator
Rubella & CMV IgM Calibrator Set
BIO-RAD LABORATORIES, INC.
6633800
Not in Commercial Distribution

  • 00847865001137 ()

  • 3 Vials
  • Total Volume: 0.5 Milliliter
6633800

  • Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, calibrator
  • Rubella virus immunoglobulin M (IgM) antibody IVD, reagent
Marsorb G, 10.0 mL
MARDX DIAGNOSTICS, INC.
41-9002
In Commercial Distribution

  • 05391516747738 ()
41-9002

  • Borrelia burgdorferi immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
  • Helicobacter pylori immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
  • Bordetella pertussis immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA)
FLEX Polyclonal Rabbit Anti-Human IgM Ready-to-Use (Link)
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
IR513
In Commercial Distribution

  • 05700572029496 ()

  • 40-60 Tests


  • Total immunoglobulin M (IgM total) IVD, antibody
Polyclonal Rabbit Anti-Human IgM/HRP
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
P0215
In Commercial Distribution

  • 05700572007364 ()

  • Total Volume: 2 Milliliter


  • Total immunoglobulin M (IgM total) IVD, antibody
Polyclonal Rabbit Anti-Human IgM/FITC
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
F0203
In Commercial Distribution

  • 05700572002529 ()

  • Total Volume: 2 Milliliter


  • Total immunoglobulin M (IgM total) IVD, antibody
Polyclonal Rabbit Anti-Human IgM
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
A0426
In Commercial Distribution

  • 05700572001416 ()

  • Total Volume: 2 Milliliter


  • Total immunoglobulin M (IgM total) IVD, antibody
Polyclonal Rabbit Anti-Human IgM
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
A0425
In Commercial Distribution

  • 05700572001409 ()

  • Total Volume: 1 Milliliter


  • Total immunoglobulin M (IgM total) IVD, antibody
Polyclonal Rabbit Anti-Human IgM/RPE, Rabbit F(ab')2
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
R5111
In Commercial Distribution

  • 05700572516286 ()

  • Total Volume: 1 Milliliter


  • Total immunoglobulin M (IgM total) IVD, antibody
Polyclonal Rabbit Anti-Human IgM/FITC Rabbit F(ab')2
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
F0058
In Commercial Distribution

  • 05700572515647 ()

  • Total Volume: 1 Milliliter


  • Total immunoglobulin M (IgM total) IVD, antibody
For the quantitative in vitro determination of IgM in serum and plasma
RANDOX LABORATORIES LIMITED
IM7977
In Commercial Distribution

  • 05055273204025 ()
IM7977

  • Total immunoglobulin M (IgM total) IVD, antibody
For the quantitative in vitro determination of IgM in serum and plasma
RANDOX LABORATORIES LIMITED
IM3834
In Commercial Distribution

  • 05055273204001 ()
IM3834

  • Total immunoglobulin M (IgM total) IVD, antibody
Immunoglobulin M (8H6) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of immunoglobulin M in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0278
In Commercial Distribution

  • 05055331318077 ()
PA0278

  • Total immunoglobulin M (IgM total) IVD, antibody
No Description
THE BINDING SITE GROUP LIMITED
NQ626.OPT
In Commercial Distribution

  • 05051700019453 ()


  • Total immunoglobulin M (IgM total) IVD, control
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