Identity
- Trade Name
- Alere™ i Instrument FDA UDI
- Generic Name
- Isothermal nucleic acid amplification analyser IVD, laboratory FDA UDI
- Device Name
- The Alere™ i Instrument is a portable, fluorescence based instrument intended to be used for the processing and analysis of Alere molecular diagnostic assays. FDA UDI
- Model / Reference
- EQ00200X FDA UDI
- Description
- The Alere™ i Instrument is a portable, fluorescence based instrument intended to be used for the processing and analysis of Alere molecular diagnostic assays. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00811877010821 FDA UDI
- 510(k) Number
- K141520 FDA UDI
- FDA Product Code
- OOI FDA UDI
- GMDN Term
- Isothermal nucleic acid amplification analyser IVD, laboratory FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.2570 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Isothermal nucleic acid amplification analyser IVD, laboratory
Alere™ i Instrument by Alere Scarborough, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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
- Alere Scarborough, Inc.
Sources (1)
- FDA UDI 25d898b5-005e-450f-95d8-9e4adce5d4d0 34 fields · synced May 30, 2026