Identity
- Trade Name
- IgE AccuLite CLIA Test System - 960 Wells FDA UDI
- Generic Name
- Total immunoglobulin E (IgE total) IVD, kit, chemiluminescent immunoassay FDA UDI
- Model / Reference
- 2575-300 FDA UDI
Identifiers
- Catalog Number
- 2575-300E FDA UDI
- Primary DI / UDI-DI
- 00816870021959 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Width — 12 Inch FDA UDI
Category: Total immunoglobulin E (IgE total) IVD, kit, chemiluminescent immunoassay
IgE AccuLite CLIA Test System - 960 Wells by Monobind, Inc. — 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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- Elecsys IgE II Immunoassay — Roche Diagnostics Corp. · Class II
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- Atellica IM tIgE — Siemens Healthcare Diagnostics · Class II
- Atellica IM tIgE — Siemens Healthcare Diagnostics · Class II
- IMMULITE® 2000 Systems TIE Total IgE — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · 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
- Monobind, Inc.
Sources (1)
- FDA UDI 30bfe10e-939b-48c4-a675-ad268c1ca362 36 fields · synced May 30, 2026