Definition: Intended For In Vitro Diagnostic Use As An Aid In The Clinical Diagnosis Of IgE Mediated Allergic Disorders In Conjunction With Other Clinical Findings, And Is To Be Used In Clinical Laboratories. FDA Has Exempted These Devices From The Premarket Not
| Device Type ID | 3108 |
| Device Name | System, Test, Radioallergosorbent (rast) Immunological, Exempt Allergens |
| Physical State | May Include Instruments (as A Test System), Calibrators, And Controls |
| Technical Method | Immunoassay Containing Allergenic Material To Capture Allergen-specific IgE |
| Target Area | Blood, Serum, And Plasma |
| Regulation Description | Radioallergosorbent (RAST) Immunological Test System. |
| Regulation Medical Specialty | Immunology |
| Review Panel | Immunology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
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| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 866.5750 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PUW |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |