Identity
- Trade Name
- Access Total IgE Calibrator S0 FDA UDI
- Generic Name
- Total immunoglobulin E (IgE total) IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- The Access Total IgE Calibrator S0 is intended for use with the Access Total IgE assay to dilute patient samples containing analyte concentrations greater than the analyte specific S6 calibrator. FDA UDI
- Model / Reference
- 35006 FDA UDI
- Description
- The Access Total IgE Calibrator S0 is intended for use with the Access Total IgE assay to dilute patient samples containing analyte concentrations greater than the analyte specific S6 calibrator. FDA UDI
Identifiers
- Catalog Number
- 35006 FDA UDI
- Primary DI / UDI-DI
- 15099590221300 FDA UDI
- FDA Product Code
- DGC FDA UDI
- GMDN Term
- Total immunoglobulin E (IgE total) IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5510 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Category: Total immunoglobulin E (IgE total) IVD, kit, chemiluminescent immunoassay
Access Total IgE Calibrator S0 by Beckman Coulter, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total immunoglobulin E (IgE total) IVD, kit, chemiluminescent immunoassay.
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- IMMULITE®/IMMULITE® 1000 Systems TIE Total IgE — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Elecsys IgE II Immunoassay — Roche Diagnostics Corp. · Class II
- Atellica IM tIgE — Siemens Healthcare Diagnostics · Class II
- IgE AccuLite CLIA Test System - 960 Wells — MONOBIND, INC. · Class II
- Atellica IM tIgE — Siemens Healthcare Diagnostics · Class II
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
- Beckman Coulter, Inc.
Sources (1)
- FDA UDI ed981e14-eabe-4e34-ae63-2513f138fba5 34 fields · synced Jun 7, 2026