Identity
- Trade Name
- Alere Reader Calibration Check Card FDA UDI
- Generic Name
- Optical laboratory instrument performance standard calibrator/control IVD, reusable FDA UDI
- Device Name
- A calibration check card verifies that the Alere™ Reader is functioning correctly FDA UDI
- Model / Reference
- LFR-003 FDA UDI
- Description
- A calibration check card verifies that the Alere™ Reader is functioning correctly FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10811877011009 FDA UDI
- 510(k) Number
- K162642 FDA UDI
- GMDN Term
- Optical laboratory instrument performance standard calibrator/control IVD, reusable FDA UDI
Classification
- Commercial Distribution
- Not 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Alere Reader Calibration Check Card by Alere Scarborough, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K162642 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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Alere Scarborough, Inc.
Sources (1)
- FDA UDI cccac40f-10c7-4e44-9ea0-4526311fabaf 35 fields · synced Jun 8, 2026