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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ImmunoCAP Allergen w1, Common ragweed
Phadia AB
14-4162-01
In Commercial Distribution

  • 07333066001616 ()
14-4162-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen t1, Box-elder
Phadia AB
14-4161-01
In Commercial Distribution

  • 07333066001609 ()
14-4161-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen m1, Penicillium chrysogenum
Phadia AB
14-4160-01
In Commercial Distribution

  • 07333066001593 ()
14-4160-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen f3, Fish (cod)
Phadia AB
14-4159-01
In Commercial Distribution

  • 07333066001586 ()
14-4159-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen w10, Goosefoot, Lamb's quarters
Phadia AB
14-4157-01
In Commercial Distribution

  • 07333066001579 ()
14-4157-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen w9, Plantain (English), Ribwort
Phadia AB
14-4156-01
In Commercial Distribution

  • 07333066001562 ()
14-4156-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen e5, Dog dander
Phadia AB
14-4110-01
In Commercial Distribution

  • 07333066001173 ()
14-4110-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen d1, House dust mite
Phadia AB
14-4107-01
In Commercial Distribution

  • 07333066001142 ()
14-4107-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen w21, Wall pellitory
Phadia AB
14-4104-01
In Commercial Distribution

  • 07333066001111 ()
14-4104-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed
Phadia AB
14-6109-01
In Commercial Distribution

  • 07333066021706 ()
14-6109-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Specific IgE Calibrator Strip 0-100
Phadia AB
34-2275-51
In Commercial Distribution

  • 07333066000527 ()
  • 07333066019802 ()
34-2275-51

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Specific IgE Conjugate 100
Phadia AB
34-2271-61
In Commercial Distribution

  • 07333066000183 ()
  • 07333066019758 ()
34-2271-61

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Specific IgE Curve Control Strip
Phadia AB
34-2271-21
In Commercial Distribution

  • 07333066000169 ()
  • 07333066019734 ()
34-2271-21

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Specific IgE Conjugate 400
Phadia AB
34-2271-02
In Commercial Distribution

  • 07333066000152 ()
  • 07333066019727 ()
34-2271-02

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
Contains one bottle of Specific IgE Conjugate and two vials of each Specific IgE Curve Control (CC-1, CC-2) for the ImmunoCAP Specific IgE method.
Phadia AB
10-9462-02
In Commercial Distribution

  • 07333066019666 ()
10-9462-02

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
Contains one vial of each Specific IgE Calibrator (Cal-0, Cal-0.35, Cal-0.7, Cal-3.5, Cal-17.5, Cal-100) to form a complete calibration curve for the ImmunoCAP Specific IgE method.
Phadia AB
10-9460-01
In Commercial Distribution

  • 07333066019659 ()
10-9460-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
Contains three vials of each Specific IgE Curve Control (CC-1, CC-2) for the ImmunoCAP Specific IgE method.
Phadia AB
10-9408-01
In Commercial Distribution

  • 07333066019604 ()
10-9408-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen i216, Allergen component rApi m 5, Honey bee
Phadia AB
14-6016-01
In Commercial Distribution

  • 07333066017549 ()
14-6016-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen i215, Allergen component rApi m 3, Honey bee
Phadia AB
14-6015-01
In Commercial Distribution

  • 07333066017532 ()
14-6015-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen i214, Allergen component rApi m 2, Honey bee
Phadia AB
14-6014-01
In Commercial Distribution

  • 07333066017525 ()
14-6014-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal (alpha-Gal) Thyroglobulin, bovine
Phadia AB
14-5997-02
In Commercial Distribution

  • 07333066017518 ()
14-5997-02

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen e231, Allergen component rFel d 7 Cat
Phadia AB
14-6082-01
In Commercial Distribution

  • 07333066016924 ()
14-6082-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen e230, Allergen component rCan f 6 Dog
Phadia AB
14-6081-01
In Commercial Distribution

  • 07333066016917 ()
14-6081-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen f447, Allergen component rAra h 6 Peanut
Phadia AB
14-6041-01
In Commercial Distribution

  • 07333066016009 ()
14-6041-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen w1, Common ragweed
Phadia AB
14-4531-01
In Commercial Distribution

  • 07333066015903 ()
14-4531-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen i217, Allergen component rApi m 10, Honey bee
Phadia AB
14-6004-01
In Commercial Distribution

  • 07333066015071 ()
14-6004-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
QC Sets and Panels: Helix Elite™ Extended Enteric Bacterial Verification Panel (Inactivated Pellet)
MICROBIOLOGICS INC.
8191
In Commercial Distribution

  • 70845357041363 ()
8191

  • Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Comprehensive Enteric Bacterial Control Panel (Inactivated Pellet)
MICROBIOLOGICS INC.
8231
In Commercial Distribution

  • 70845357042704 ()
8231

  • Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, control
BD Directigen™ Specimen Buffer Solution
BECTON, DICKINSON AND COMPANY
256391
Not in Commercial Distribution

  • 00382902563914 ()

  • Total Volume: 8 Milliliter
256391

  • Multiple meningitis-associated bacteria antigen IVD, kit, agglutination
BD Directigen™ Neisseria meningitidis Group B and E. coli K1 Test Kit
BECTON, DICKINSON AND COMPANY
255560
Not in Commercial Distribution

  • 00382902555605 ()
255560

  • Multiple meningitis-associated bacteria antigen IVD, kit, agglutination
BD Directigen™ Group B Strep Test
BECTON, DICKINSON AND COMPANY
255460
Not in Commercial Distribution

  • 00382902554608 ()
255460

  • Multiple meningitis-associated bacteria antigen IVD, kit, agglutination
BD Directigen™ Meningitis Combo Test Cards
BECTON, DICKINSON AND COMPANY
252480
Not in Commercial Distribution

  • 00382902524809 ()
252480

  • Multiple meningitis-associated bacteria antigen IVD, kit, agglutination
BD Directigen™ Meningitis Combo Test Kit
BECTON, DICKINSON AND COMPANY
252360
Not in Commercial Distribution

  • 00382902523604 ()
252360

  • Multiple meningitis-associated bacteria antigen IVD, kit, agglutination
BD Directigen™ H. influenzae type b Test
BECTON, DICKINSON AND COMPANY
252260
Not in Commercial Distribution

  • 00382902522607 ()
252260

  • Multiple meningitis-associated bacteria antigen IVD, kit, agglutination
BD Directigen™ S. pneumoniae Test
BECTON, DICKINSON AND COMPANY
251960
Not in Commercial Distribution

  • 00382902519607 ()
251960

  • Multiple meningitis-associated bacteria antigen IVD, kit, agglutination
BD Directigen™ Neisseria meningitidis Test Kit Groups A, C, Y and W135
BECTON, DICKINSON AND COMPANY
250160
Not in Commercial Distribution

  • 00382902501602 ()
250160

  • Multiple meningitis-associated bacteria antigen IVD, kit, agglutination
Kit BD MAX EXT Enteric Bacterial Panel
BECTON, DICKINSON AND COMPANY
443812
In Commercial Distribution

  • 00382904438128 ()
443812

  • Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)
Kit BD Max Enteric Bacterial Panel USA
Geneohm Sciences Canada Inc
443378
Not in Commercial Distribution

  • 00382904433789 ()
443378

  • Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)
Kit BD MAX Enteric Bacterial Panel
BECTON, DICKINSON AND COMPANY
442963
In Commercial Distribution

  • 00382904429638 ()
442963

  • Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
REMEL EUROPE LIMITED
R30859001
In Commercial Distribution

  • 05056080501581 ()


  • Multiple meningitis-associated bacteria antigen IVD, kit, agglutination
No Description
REMEL EUROPE LIMITED
R30858701
In Commercial Distribution

  • 05056080501574 ()


  • Multiple meningitis-associated bacteria antigen IVD, kit, agglutination
No Description
REMEL EUROPE LIMITED
R30859602
In Commercial Distribution

  • 05056080500997 ()


  • Multiple meningitis-associated bacteria antigen IVD, kit, agglutination
No Description
REMEL EUROPE LIMITED
R30859502
In Commercial Distribution

  • 05056080500980 ()


  • Multiple meningitis-associated bacteria antigen IVD, kit, agglutination
No Description
REMEL EUROPE LIMITED
R30859203
In Commercial Distribution

  • 05056080500973 ()


  • Multiple meningitis-associated bacteria antigen IVD, kit, agglutination
No Description
REMEL EUROPE LIMITED
R30858801
In Commercial Distribution

  • 05056080500966 ()


  • Multiple meningitis-associated bacteria antigen IVD, kit, agglutination
Drill Sleeve Insert, MIS
Stryker GmbH
542116
In Commercial Distribution

  • 07613327625066 ()
542116

  • Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Mkl Diagnostics AB
10-5593-12
In Commercial Distribution

  • 07350049850238 ()


  • Multiple meningitis-associated bacteria antigen IVD, control
No Description
Mkl Diagnostics AB
10-5592-12
In Commercial Distribution

  • 07350049850221 ()
10-5592-12

  • Multiple meningitis-associated bacteria antigen IVD, kit, agglutination
No Description
Hologic, Inc.
PROGASTRO SSCS ASSAY
Not in Commercial Distribution

  • 15420045506350 ()
303278

  • Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)
BD Directigen™ Meningitis Test Negative Control Reagent
BECTON, DICKINSON AND COMPANY
252350
Not in Commercial Distribution

  • 30382902523506 ()
  • 00382902523505 ()

  • Total Volume: 9 Milliliter
252350

  • Multiple meningitis-associated bacteria antigen IVD, control
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