Identity
- Trade Name
- Lactoferrin CLIA Re-Calibrator and Control Set FDA UDI
- Generic Name
- Lactoferrin IVD, calibrator FDA UDI
- Device Name
- The Lactoferrin CLIA Re-Calibrator and Control Set is an accessory used in conjunction with the Lactoferrin CLIA Kit (80-LACHU-FC100, 80-LACHU-FC900) by trained laboratory personnel. For In Vitro Diagnostic Use in the United States. FDA UDI
- Model / Reference
- 80-LACHU-FCSET FDA UDI
- Description
- The Lactoferrin CLIA Re-Calibrator and Control Set is an accessory used in conjunction with the Lactoferrin CLIA Kit (80-LACHU-FC100, 80-LACHU-FC900) by trained laboratory personnel. For In Vitro Diagnostic Use in the United States. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B24280LACHUFCSET0 FDA UDI
- FDA Product Code
- DEG FDA UDI
- GMDN Term
- Lactoferrin IVD, calibrator FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.5570 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Lactoferrin IVD, calibratorLactoferrin IVD, control
Lactoferrin CLIA Re-Calibrator and Control Set by American Laboratory Products Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 I | Pending data |
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Manufacturer
- Manufacturer
- American Laboratory Products Company
Sources (1)
- FDA UDI 93c7f93f-3755-4722-a05b-797fc7da6d59 34 fields · synced Jun 8, 2026