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In vitro diagnostic medical devices
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Immunochemistry (immunology)
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Allergy
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Immunoglobulin e - specific, monotest/monoresult
Immunoglobulin e - specific, monotest/monoresult
W01020202
1,472 devices
Allergen Discs Reismehlkäfer (T. confusum)
Gold Standard Diagnostics Kassel GmbH
·
,
Germany
IVD General
CE/IVDD
ImmunoCAP Allergen t8, Elm
Phadia AB
·
,
Sweden
Class B
CE/IVDR
GUDID
on market
Allergen Discs Wespengift (V. germanica)
Gold Standard Diagnostics Kassel GmbH
·
,
Germany
IVD General
CE/IVDD
Sharay Specific IgE (19 Allergens) (CLIA)
C-Luminary Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
ImmunoCAP Allergen k77, Isocyanate HDI
Phadia AB
·
,
Sweden
Class B
CE/IVDR
GUDID
on market
IMMULITE 2000 Enterotoxin A Specific Allergen
Siemens Healthcare Diagnostics Products Limited
·
,
United Kingdom
Class B
CE/IVDR
Allergen Discs Amoxicillin
Gold Standard Diagnostics Kassel GmbH
·
,
Germany
IVD General
CE/IVDD
Allergen Discs Epithelien
Gold Standard Diagnostics Kassel GmbH
·
,
Germany
IVD General
CE/IVDD
ImmunoCAP Allergen rx1, Regional
Phadia AB
·
,
Sweden
Class B
CE/IVDR
Allergen Discs Pepperoni
Gold Standard Diagnostics Kassel GmbH
·
,
Germany
IVD General
CE/IVDD
BioCLIA Allergy Reagent Kit, F17
HOB Biotech Group Corp., Ltd.
·
,
China
IVD General
CE/IVDD
ImmunoCAP Allergen f328, Fig
Phadia AB
·
,
Sweden
Class B
CE/IVDR
Sharay Specific IgE (Mixed Allergens 2) (CLIA)
C-Luminary Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Allergen Discs Kakao
Gold Standard Diagnostics Kassel GmbH
·
,
Germany
IVD General
CE/IVDD
ImmunoCAP Allergen f224, Poppy seed
Phadia AB
·
,
Sweden
Class B
CE/IVDR
d1 CLIA Microparticles
Autobio Diagnostics Co., Ltd.
·
,
China
Class B
CE/IVDR
BioCLIA Allergy Reagent Kit, D201
HOB Biotech Group Corp., Ltd.
·
,
China
IVD General
CE/IVDD
ImmunoCAP Allergen f260, Broccoli
Phadia AB
·
,
Sweden
Class B
CE/IVDR
GUDID
on market
ImmunoCAP Allergen o215, Component nGal-alpha-1, 3-Gal (alpha-Gal) Thyroglobuli…
Phadia AB
·
,
Sweden
Class B
FDA 510(k)
K200279
Active
Cleared 1 May 2020
CE/IVDR
ImmunoCAP Allergen f81, Cheese, cheddar type
Phadia AB
·
,
Sweden
Class B
CE/IVDR
GUDID
on market
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