Home › Device types › DHB
System, Test, Radioallergosorbent (Rast) Immunological
FDA product code DHB · Class 2 · Immunology
893
Registered devices
60
Adverse events
27
Recalls
268
510(k) clearances
Devices with this code
IMMULITE®2000 Systems 3gAllergy™ Chocolate — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDImmunoCAP Allergen f75, Egg yolk — Phadia ABImmunoCAP Allergen f353, Allergen component rGly m 4 PR-10, Soy — Phadia ABNOVEOS House Dust Mite, Dermatophagoides farinae — HYCOR BIOMEDICAL LLCIMMULITE®2000 Systems 3gAllergy™ Rice — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDImmunoCAP Allergen f84, Kiwi fruit — Phadia ABImmunoCAP Allergen f24, Shrimp — Phadia ABImmunoCAP Allergen w11, Saltwort (prickly), Russian thistle — Phadia ABImmunoCAP Allergen f14, Soybean — Phadia ABOPTIGEN® Allergen-Specific IgE Assay - Universal 20 Panel — Minaris Medical America, Inc.ImmunoCAP Allergen f56, Foxtail millet — Phadia ABImmunoCAP Allergen f41, Salmon — Phadia ABImmunoCAP Allergen w20, Nettle — Phadia ABImmunoCAP Allergen w7, Marguerite, Ox-eye daisy — Phadia ABImmunoCAP Allergen f256, Walnut — Phadia ABIMMULITE®2000 Systems 3gAllergy™ Poplar — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDImmunoCAP Allergen w19, Wall pellitory — Phadia ABCLA® Allergen-Specific IgE Assay - Eastern — Minaris Medical America, Inc.IMMULITE®2000 Systems 3gAllergy™ Latex — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDIMMULITE®2000 Systems 3gAllergy™ nDer p 2 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDImmunoCAP Allergen t227, Allergen component nOle e 7 LTP, Olive — Phadia ABIMMULITE®2000 Systems 3gAllergy™ Yellow Hornet — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDIMMULITE®2000 Systems 3gAllergy™ Plum — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDIMMULITE®2000 Systems 3gAllergy™ Dermatophagoides farinae — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
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