Identity
- Trade Name
- Elecsys IgE II Immunoassay FDA UDI
- Generic Name
- Total immunoglobulin E (IgE total) IVD, kit, chemiluminescent immunoassay FDA UDI
- Model / Reference
- 4827031190 FDA UDI
Identifiers
- Catalog Number
- 4827031190 FDA UDI
- Primary DI / UDI-DI
- 04015630922369 FDA UDI
- 510(k) Number
- K061970 FDA UDI
- FDA Product Code
- JHR 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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: Total immunoglobulin E (IgE total) IVD, kit, chemiluminescent immunoassay
Elecsys IgE II Immunoassay by Roche Diagnostics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Total immunoglobulin E (IgE total) IVD, kit, chemiluminescent immunoassay.
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- IgE AccuLite CLIA Test System - 192 Wells — MONOBIND, INC. · Class II
Cleared under the same submission
K061970 also covers:
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
- Roche Diagnostics Corp.
Sources (1)
- FDA UDI 699ee3b9-1eac-40ef-83ca-259d1911cb48 35 fields · synced Jun 8, 2026