Identity
- Trade Name
- IMMULITE®2000 Systems 3gAllergy™ Grapefruit FDA UDI
- Generic Name
- Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent FDA UDI
- Device Name
- Grapefruit-Specific IgE - IMMULITE - RGT FDA UDI
- Model / Reference
- 10385713 FDA UDI
- Description
- Grapefruit-Specific IgE - IMMULITE - RGT FDA UDI
Identifiers
- Catalog Number
- F209L2 FDA UDI
- Primary DI / UDI-DI
- 00630414996486 FDA UDI
- 510(k) Number
- K091984 FDA UDI
- FDA Product Code
- DHB FDA UDI
- GMDN Term
- Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5750 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
IMMULITE®2000 Systems 3gAllergy™ Grapefruit by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID
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Also classified as Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent.
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- Sharay Specific IgE (Mix of 22 items) (CLIA) — C-Luminary Biotechnology Co., Ltd. · IVD General
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Cleared under the same submission
K091984 also covers:
- IMMULITE®2000 Systems 3gAllergy™ Black Pepper — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®2000 Systems 3gAllergy™ Broccoli — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®2000 Systems 3gAllergy™ Cabbage — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®2000 Systems 3gAllergy™ Cheese-Mold Type — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®2000 Systems 3gAllergy™ Cherry — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®2000 Systems 3gAllergy™ Chesnut — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®2000 Systems 3gAllergy™ Chocolate — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®2000 Systems 3gAllergy™ Coffee — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®2000 Systems 3gAllergy™ Cucumber — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®2000 Systems 3gAllergy™ Egg Pineapple — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®2000 Systems 3gAllergy™ Grape — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®2000 Systems 3gAllergy™ Haddock — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics Products Ltd
Sources (1)
- FDA UDI 1a2118b0-b0b9-48b2-a6f6-c1f84e624256 37 fields · synced May 31, 2026