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
HYCOR BIOMEDICAL LLC
K332020-2Z
In Commercial Distribution

  • 00816879029628 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
HYCOR BIOMEDICAL LLC
63180Z
In Commercial Distribution

  • 00816879029550 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
HYCOR BIOMEDICAL LLC
63125Z
In Commercial Distribution

  • 00816879029499 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
HYCOR BIOMEDICAL LLC
K33218085-4Z
In Commercial Distribution

  • 00816879029468 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
HYCOR BIOMEDICAL LLC
K332065-2
In Commercial Distribution

  • 00816879028881 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
HYCOR BIOMEDICAL LLC
K33218085-4
In Commercial Distribution

  • 00816879028850 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
HYCOR BIOMEDICAL LLC
K332030-2
In Commercial Distribution

  • 00816879028836 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
HYCOR BIOMEDICAL LLC
K332020-2
In Commercial Distribution

  • 00816879028829 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
HYCOR BIOMEDICAL LLC
63125
In Commercial Distribution

  • 00816879023251 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
HYCOR BIOMEDICAL LLC
63180
In Commercial Distribution

  • 00816879023077 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
HYCOR BIOMEDICAL LLC
63145
Not in Commercial Distribution

  • 00816879023015 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
HYCOR BIOMEDICAL LLC
74155
Not in Commercial Distribution

  • 00816879022308 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
The DRG IgE ELISA is intended for the quantitative determination of immunoglobulin E in human serum. This assay is to be used for the assessment of hypersensitive and allergic reactions in patients.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-1788
In Commercial Distribution

  • 04048474017885 ()
EIA-1788

  • 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)
ImmunoCAP Allergen d202, Allergen component rDer p 1, House dust mite
Phadia AB
14-5996-01
In Commercial Distribution

  • 07333066011073 ()
14-5996-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen f442, Allergen component rJug r 3 LTP, Walnut
Phadia AB
14-5954-01
In Commercial Distribution

  • 07333066011059 ()
14-5954-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen f441, Allergen component rJug r 1, Walnut
Phadia AB
14-5762-01
In Commercial Distribution

  • 07333066011042 ()
14-5762-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen f443, Allergen component rAna o 3, Cashew nut
Phadia AB
14-5760-01
In Commercial Distribution

  • 07333066011035 ()
14-5760-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen f440, Allergen component nCor a 9, Hazelnut
Phadia AB
14-5758-01
In Commercial Distribution

  • 07333066011028 ()
14-5758-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen e229, Allergen component rCan f 4 Dog
Phadia AB
14-5755-01
In Commercial Distribution

  • 07333066011011 ()
14-5755-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen f439, Allergen component rCor a 14, Hazelnut
Phadia AB
14-5754-01
In Commercial Distribution

  • 07333066011004 ()
14-5754-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen f98, Gliadin
Phadia AB
14-5752-01
In Commercial Distribution

  • 07333066010991 ()
14-5752-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen t224, Allergen Component rOle e 1, Olive
Phadia AB
14-5705-01
In Commercial Distribution

  • 07333066010960 ()
14-5705-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen e228, Allergen component rFel d 4, Cat
Phadia AB
14-5702-01
In Commercial Distribution

  • 07333066010939 ()
14-5702-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat
Phadia AB
14-5701-01
In Commercial Distribution

  • 07333066010922 ()
14-5701-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen e227, Allergen component rEqu c 1, Horse
Phadia AB
14-5700-01
In Commercial Distribution

  • 07333066010915 ()
14-5700-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen m229, Allergen component rAlt a 1, Alternaria alternata
Phadia AB
14-5346-01
In Commercial Distribution

  • 07333066010540 ()
14-5346-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen t225, Allergen component rBet v 6 Birch
Phadia AB
14-5345-01
In Commercial Distribution

  • 07333066010533 ()
14-5345-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen f354, Allergen component rBer e 1, Brazil nut
Phadia AB
14-5343-01
In Commercial Distribution

  • 07333066010519 ()
14-5343-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen f352, Allergen component rAra h 8 PR-10, Peanut
Phadia AB
14-5341-01
In Commercial Distribution

  • 07333066010496 ()
14-5341-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen f353, Allergen component rGly m 4 PR-10, Soy
Phadia AB
14-5340-01
In Commercial Distribution

  • 07333066010489 ()
14-5340-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen o214, Allergen component MUXF3 CCD, Bromelain
Phadia AB
14-5339-01
In Commercial Distribution

  • 07333066010465 ()
14-5339-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen g215, Allergen component rPhl p 5b Timothy
Phadia AB
14-5338-01
In Commercial Distribution

  • 07333066010441 ()
14-5338-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen c7, Cefaclor
Phadia AB
14-5336-10
In Commercial Distribution

  • 07333066010427 ()
14-5336-10

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
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