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IMMULITE® 2000 Systems SPE Specific IgE Universal Kit
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- IMMULITE® 2000 Systems SPE Specific IgE Universal Kit FDA UDI
- Generic Name
- Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- Allergen-Specific IgE - IMMULITE - RGT - 600 Tests FDA UDI
- Model / Reference
- 10708840 FDA UDI
- Description
- Allergen-Specific IgE - IMMULITE - RGT - 600 Tests FDA UDI
Identifiers
- Catalog Number
- L2KUN6(D) FDA UDI
- Primary DI / UDI-DI
- 00630414982939 FDA UDI
- 510(k) Number
- K101572 FDA UDI
- FDA Product Code
- DHB FDA UDI
- GMDN Term
- Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay 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
Yes
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, kit, chemiluminescent immunoassay
IMMULITE® 2000 Systems SPE Specific IgE Universal Kit by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay.
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- CLA® Allergen-Specific IgE Assay - Moderate Food Panel — Minaris Medical America, Inc. · Class II
- OPTIGEN® Allergen-Specific IgE Assay - US Food 25 (100 ND) — Minaris Medical America, Inc. · Class II
- OPTIGEN® Allergen-Specific IgE Assay - US Mix 36 Panel — Minaris Medical America, Inc. · Class II
- CLA® Allergen-Specific IgE Assay - Eastern — Minaris Medical America, Inc. · Class II
- OPTIGEN® Allergen-Specific IgE Assay - US Environmental 36 (40ND) — Minaris Medical America, Inc. · Class II
Cleared under the same submission
K101572 also covers:
- IMMULITE®2000 Systems 3gAllergy™ Basil — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®2000 Systems 3gAllergy™ Cacao — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®2000 Systems 3gAllergy™ Oregano — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®2000 Systems 3gAllergy™ Parsley — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®2000 Systems 3gAllergy™ Pine Nut — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®2000 Systems 3gAllergy™ Vanilla — 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 69e0ed72-0065-40c3-8b03-a87d0479174b 37 fields · synced May 30, 2026