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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No Description
InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)
HISS5544
In Commercial Distribution

  • 08800039305754 ()


  • Haemoglobin E (HbE) IVD, calibrator
IgE - CENTAUR - RGT - 250 tests
Siemens Healthcare Diagnostics Inc.
10309986
In Commercial Distribution

  • 00630414177489 ()
  • 00630414003269 ()
110778

  • Total immunoglobulin E (IgE total) IVD, kit, chemiluminescent immunoassay
IgE - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10309985
In Commercial Distribution

  • 00630414177472 ()
110777

  • Total immunoglobulin E (IgE total) IVD, kit, chemiluminescent immunoassay
IgE (tIgE) Atellica IM - RGT 50T
Siemens Healthcare Diagnostics Inc.
10995615
In Commercial Distribution

  • 00630414599380 ()
10995615

  • Total immunoglobulin E (IgE total) IVD, kit, chemiluminescent immunoassay
IgE (tIgE) Atellica IM – RGT 250T
Siemens Healthcare Diagnostics Inc.
10995614
In Commercial Distribution

  • 00630414599373 ()
  • 00630414007601 ()
10995614

  • Total immunoglobulin E (IgE total) IVD, kit, chemiluminescent immunoassay
Plastic Syringe Tips, Type A, Box of 25
Gc America Inc.
159225
In Commercial Distribution

  • 00386040004124 ()
  • 10386040004121 ()
159225

  • Haemoglobin E (HbE) IVD, calibrator
GC Plastic Syringe Tips Package of 10
Gc America Inc.
159310
In Commercial Distribution

  • 00386040006302 ()
  • 10386040006309 ()
159310

  • Haemoglobin E (HbE) IVD, calibrator
GC Plastic Syringe Tips, Package of 100
Gc America Inc.
159300
In Commercial Distribution

  • 00386040006289 ()
  • 10386040006286 ()
159300

  • Haemoglobin E (HbE) IVD, calibrator
The Access Total IgE assay is a paramagnetic particle, chemiluminescent immunoassay for the qualitative determination of total E (IgE) levels in human serum and plasma (heparin, EDTA) using the Access Immunoassay Systems.
Beckman Coulter, Inc.
35000
Not in Commercial Distribution

  • 15099590221324 ()
35000

  • Total immunoglobulin E (IgE total) IVD, kit, chemiluminescent immunoassay
The Access Total IgE Calibrators are intended to calibrate the Access Total IgE assay for the quantitative determination of total IgE levels in human serum and plasma (heparin, EDTA) using the Access Immunoassay Systems.
Beckman Coulter, Inc.
35005
Not in Commercial Distribution

  • 15099590221317 ()
35005

  • Total immunoglobulin E (IgE total) IVD, kit, chemiluminescent immunoassay
The Access Total IgE Calibrator S0 is intended for use with the Access Total IgE assay to dilute patient samples containing analyte concentrations greater than the analyte specific S6 calibrator.
Beckman Coulter, Inc.
35006
In Commercial Distribution

  • 15099590221300 ()
35006

  • Total immunoglobulin E (IgE total) IVD, kit, chemiluminescent immunoassay
No Description
MONOBIND, INC.
13025-300
In Commercial Distribution

  • 00816870024400 ()

  • Width: 7.75 Inch
13025-300A

  • Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA)
No Description
MONOBIND, INC.
2525-300
In Commercial Distribution

  • 00816870020273 ()

  • Width: 12 Inch
2525-300E

  • Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA)
No Description
MONOBIND, INC.
2525-300
In Commercial Distribution

  • 00816870020266 ()

  • Width: 12 Inch
2525-300D

  • Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA)
No Description
MONOBIND, INC.
2525-300
In Commercial Distribution

  • 00816870020259 ()

  • Width: 7.75 Inch
2525-300B

  • Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA)
No Description
MONOBIND, INC.
2525-300
In Commercial Distribution

  • 00816870020242 ()

  • Width: 7.75 Inch
2525-300A

  • Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Total IgE Anti-IgE
Phadia AB
14-4509-01
In Commercial Distribution

  • 07333066004037 ()
14-4509-01

  • Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Total IgE Conjugate 400
Phadia AB
34-2325-42
In Commercial Distribution

  • 07333066000664 ()
  • 07333066019864 ()
34-2325-42

  • Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Total IgE Calibrator Strip
Phadia AB
34-2274-81
In Commercial Distribution

  • 07333066000367 ()
  • 07333066019796 ()
34-2274-81

  • Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Total IgE Curve Control Strip
Phadia AB
34-2274-51
In Commercial Distribution

  • 07333066000220 ()
  • 07333066019789 ()
34-2274-51

  • Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Total IgE Conjugate 100
Phadia AB
34-2272-22
In Commercial Distribution

  • 07333066000206 ()
  • 07333066019772 ()
34-2272-22

  • Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA)
Contains one bottle of Total IgE Conjugate and four vials of each Total IgE Curve Control (CC-1, CC-2) for the ImmunoCAP Total IgE method.
Phadia AB
10-9517-02
In Commercial Distribution

  • 07333066019673 ()
10-9517-02

  • Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA)
Contains three vials of each Total IgE Curve Control (CC-1, CC-2) for the ImmunoCAP Total IgE method.
Phadia AB
10-9257-01
In Commercial Distribution

  • 07333066019529 ()
10-9257-01

  • Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA)
Contains one vial of each Total IgE Calibrator (Cal-2, Cal-10, Cal-50, Cal-200, Cal-1000, Cal-5000) to form a complete calibration curve for the ImmunoCAP Total IgE method.
Phadia AB
10-9252-01
In Commercial Distribution

  • 07333066019512 ()
10-9252-01

  • Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA)
The Total IgE ELISA is intended for use in the quantitative determination of immunoglobulin E in human serum. The assay is to be used for the assessment of hypersensitive and allergic reactions in patients.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
25-IGEHU-E01
Not in Commercial Distribution

  • B24225IGEHUE010 ()
25-IGEHU-E01

  • Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA)
Quantia IgE Calibrators
ABBOTT LABORATORIES
06K5004
In Commercial Distribution

  • 00380740156367 ()
06K5004

  • Total immunoglobulin E (IgE total) IVD, calibrator
IgE Calibrators
ABBOTT LABORATORIES
01R1302
In Commercial Distribution

  • 00380740153694 ()
01R1302

  • Total immunoglobulin E (IgE total) IVD, calibrator
No Description
TOSOH CORPORATION
N/A
In Commercial Distribution

  • 04560189211070 ()


  • Total immunoglobulin E (IgE total) IVD, calibrator
Quantia IgE Calibrators
ABBOTT LABORATORIES
6K50-02
In Commercial Distribution

  • 00380740030100 ()
06K5002

  • Total immunoglobulin E (IgE total) IVD, calibrator
Anti-HBe PC Elecsys
Roche Diagnostics GmbH
11876384160
In Commercial Distribution

  • 04015630938872 ()
11876384160

  • Hepatitis E virus total antibody IVD, control
No Description
TOSOH CORPORATION
N/A
In Commercial Distribution

  • 14560189210155 ()
  • 04560189210158 ()


  • Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA)
Tinted Liquid
JBC and Company
E
In Commercial Distribution

  • D851E0 ()
E

  • Dental appliance fabrication material, resin
Blood Grouping Reagent Anti-e (Monoclonal) formulated for Automated Systems, Beckman Coulter® PK®7400 Systems
DIAGAST
B49558
In Commercial Distribution

  • 23661562495584 ()
B49558

  • Anti-E [RH005] red blood cell grouping IVD, antibody
Blood Grouping Reagent Anti-e (Monoclonal) formulated for Automated Systems, Beckman Coulter® PK® 7300 Systems
DIAGAST
17319
In Commercial Distribution

  • 23661562173192 ()
17319

  • Anti-E [RH005] red blood cell grouping IVD, antibody
Blood Grouping Reagent Anti-E (Monoclonal) formulated for Automated Systems, Beckman Coulter® PK® Systems
DIAGAST
17307
In Commercial Distribution

  • 23661562173079 ()
17307

  • Anti-E [RH003] red blood cell grouping IVD, antibody
Blood Grouping Reagent, Anti-e (Human/Murine Monoclonal) (P3GD512+MS63) - This reagent is designed to determine the presence of the blood group antigen e (Rh5) on the surface of human red blood cells by manual tube method.
DIAGAST
210530
In Commercial Distribution

  • 23661562105308 ()
  • 13661562105301 ()
210230

  • Anti-E [RH005] red blood cell grouping IVD, antibody
Blood Grouping Reagent, Anti-E (Human/Murine Monoclonal) (906) - This reagent is designed to determine the presence of the blood group antigen E (Rh3) on the surface of human red blood cells by manual tube method.
DIAGAST
210529
In Commercial Distribution

  • 23661562105292 ()
  • 13661562105295 ()
210529

  • Anti-E [RH003] red blood cell grouping IVD, antibody
Blood Grouping Reagent; Gel card for use with the IH-system; Card for single e (RH5) antigen typing; 288 cards of 6 microtubes
Bio-Rad Medical Diagnostics GmbH
813242100
In Commercial Distribution

  • 07611969964727 ()
813242100

  • Anti-E [RH005] red blood cell grouping IVD, antibody
Blood Grouping Reagent; Gel card for use with the IH-system; Card for single e (RH5) antigen typing; 12 cards of 6 microtubes
Bio-Rad Medical Diagnostics GmbH
813240100
In Commercial Distribution

  • 07611969964710 ()
813240100

  • Anti-E [RH005] red blood cell grouping IVD, antibody
Blood Grouping Reagent; Gel card for use with the IH-system; Card for single E (RH3) antigen typing; 288 cards of 6 microtubes
Bio-Rad Medical Diagnostics GmbH
813222100
In Commercial Distribution

  • 07611969964680 ()
813222100

  • Anti-E [RH003] red blood cell grouping IVD, antibody
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