Identity
- Trade Name
- Actalyke QC Kit - AQC-LP FDA UDI
- Generic Name
- Activated clotting time (ACT) IVD, control FDA UDI
- Model / Reference
- AQC-LP FDA UDI
Identifiers
- Primary DI / UDI-DI
- M525AQCLP0 FDA UDI
- 510(k) Number
- K061014 FDA UDI
- FDA Product Code
- JPA FDA UDI
- GMDN Term
- Activated clotting time (ACT) IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.5425 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: Activated clotting time (ACT) IVD, control
Actalyke QC Kit - AQC-LP by Helena Laboratories, Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Activated clotting time (ACT) IVD, control.
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- Whole Blood Control Level II — Analytical Control Systems · Class II
- i-STAT — Abbott Point of Care Inc. · Class II
Cleared under the same submission
K061014 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
- Helena Laboratories, Corp.
Sources (1)
- FDA UDI a05d5b69-9762-4ced-93d0-33be35aba91c 34 fields · synced Jun 9, 2026