Home › Device types › DHB
System, Test, Radioallergosorbent (Rast) Immunological
FDA product code DHB · Class 2 · Immunology
919
Registered devices
60
Adverse events
27
Recalls
269
510(k) clearances
Devices with this code
CLA® Positive Control Serum — Minaris Medical America, Inc.IMMULITE®2000 Systems 3gAllergy™ Coffee — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDImmunoCAP Allergen f424, Allergen component rAra h 3 Peanut — Phadia ABImmunoCAP Allergen g7, Common reed — Phadia ABImmunoCAP Allergen f84, Kiwi fruit — Phadia ABIMMULITE®2000 Systems 3gAllergy™ Scallop — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDRagweed, Common Ambrosia elatior (artemisiifolia) — HYCOR BIOMEDICAL LLCImmunoCAP Allergen fx23, Food — Phadia ABAlder, Smooth Alnus rugosa (serrulata) — HYCOR BIOMEDICAL LLCImmunoCAP Allergen f44, Strawberry — Phadia ABImmunoCAP Allergen m16, Curvularia lunata — Phadia ABStop Solution — Phadia ABImmunoCAP Allergen e221, Allergen component nCan f 3 Dog serum albumin — Phadia ABIMMULITE®2000 Systems 3gAllergy™ Poplar — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDImmunoCAP Allergen t17, Japanese cedar — Phadia ABIMMULITE®2000 Systems 3gAllergy™ Cladosporium herbarum — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDImmunoCAP Allergen g5, Rye-grass — Phadia ABIMMULITE®2000 Systems 3gAllergy™ Vanilla — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDIMMULITE®2000 Systems 3gAllergy™ White Bald Cypress — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDImmunoCAP Allergen m81, Staphylococcal enterotoxin B — Phadia ABPhadia 1000 — Phadia ABIMMULITE®2000 Systems 3gAllergy™ Weed Panel 3 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDIMMULITE 2000 rBet v 2 Specific Allergen — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDIMMULITE®2000 Systems 3gAllergy™ Asparagus — 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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