Identity
- Trade Name
- IMMULITE®2000 Systems 3gAllergy™ Sugar Cane FDA UDI
- Generic Name
- Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent FDA UDI
- Device Name
- Sugar Cane-Specific IgE - IMMULITE - RGT FDA UDI
- Model / Reference
- 10385724 FDA UDI
- Description
- Sugar Cane-Specific IgE - IMMULITE - RGT FDA UDI
Identifiers
- Catalog Number
- F21L2 FDA UDI
- Primary DI / UDI-DI
- 00630414978529 FDA UDI
- 510(k) Number
- K093107 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™ Sugar Cane by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID
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Cleared under the same submission
K093107 also covers:
- IMMULITE® 2000 Systems SPE 3gAllergy Specific IgE Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®2000 Systems 3gAllergy™ Brewers Yeast — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®2000 Systems 3gAllergy™ Cantaloupe — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®2000 Systems 3gAllergy™ Cinnamon — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®2000 Systems 3gAllergy™ Flounder — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®2000 Systems 3gAllergy™ Green Bean — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®2000 Systems 3gAllergy™ Green Pepper — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®2000 Systems 3gAllergy™ Halibut — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®2000 Systems 3gAllergy™ Mushroom — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®2000 Systems 3gAllergy™ Pinto Bean — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®2000 Systems 3gAllergy™ Red Kidney Bean — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®2000 Systems 3gAllergy™ Yogurt — 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 994445b4-f4a3-4a45-8df3-825ecef4b812 37 fields · synced May 30, 2026