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IMMULITE® Systems neg CONTROL 3gAllergy™ Specific IgE Negative Control
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- IMMULITE® Systems neg CONTROL 3gAllergy™ Specific IgE Negative Control FDA UDI
- Generic Name
- Allergen-specific immunoglobulin E (IgE) antibody IVD, control FDA UDI
- Device Name
- Specific IgE Neg - IMMULITE - CTL - 1x4mL FDA UDI
- Model / Reference
- 10485107 FDA UDI
- Description
- Specific IgE Neg - IMMULITE - CTL - 1x4mL FDA UDI
Identifiers
- Catalog Number
- L2SNCCM FDA UDI
- Primary DI / UDI-DI
- 00630414984599 FDA UDI
- 510(k) Number
- K013134 FDA UDI
- FDA Product Code
- DHB FDA UDI
- GMDN Term
- Allergen-specific immunoglobulin E (IgE) antibody IVD, control 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, control
IMMULITE® Systems neg CONTROL 3gAllergy™ Specific IgE Negative Control 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, control.
- NOVEOS IgE Negative Control Pack — HYCOR BIOMEDICAL LLC · Class II
- NOVEOS IgE Positive Control Pack — HYCOR BIOMEDICAL LLC · Class II
- NOVEOS IgE Negative Control Pack — HYCOR BIOMEDICAL LLC · Class II
- NOVEOS IgE Positive Control Pack — HYCOR BIOMEDICAL LLC · Class II
- IMMULITE Systems 3gAllergy Specific IgE Positive Control For D1 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- IMMULITE Systems 3gAllergy Specific IgE Positive Control for D2 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- IMMULITE Systems 3gAllerg Specific IgE Positive Control for M6 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- IMMULITE® 2000 ALLERGEN SPE Allergen Specific IgE CVM — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
Cleared under the same submission
K013134 also covers:
- IMMULITE Systems 3gAllergy Specific IgE Positive Control For D1 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE® 2000 Systems 3gAllergy™ Cultivated Wheat Grass — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®2000 Systems 3gAllergy™ Alternaria tenuis — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®2000 Systems 3gAllergy™ Bahia Grass — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®2000 Systems 3gAllergy™ Bakers Yeast — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®2000 Systems 3gAllergy™ Bermuda Grass — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®2000 Systems 3gAllergy™ Buckwheat — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®2000 Systems 3gAllergy™ Candida albicans — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®2000 Systems 3gAllergy™ Carrot — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®2000 Systems 3gAllergy™ Casein — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®2000 Systems 3gAllergy™ Celery — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®2000 Systems 3gAllergy™ Cladosporium herbarum — 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 d6333928-beea-4a99-bfeb-1d52af4dd1dd 37 fields · synced Jun 7, 2026