Identity
- Trade Name
- Whole Blood Control Level II FDA UDI
- Generic Name
- Activated clotting time (ACT) IVD, control FDA UDI
- Model / Reference
- SC-126 FDA UDI
Identifiers
- Catalog Number
- SC-126 FDA UDI
- Primary DI / UDI-DI
- 00817869020267 FDA UDI
- 510(k) Number
- K925340 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
No
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
Yes
FDA UDI
Category: Activated clotting time (ACT) IVD, control
Whole Blood Control Level II by Analytical Control Systems — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Activated clotting time (ACT) IVD, control.
- Actalyke QC Kit - AQC-LP — Helena Laboratories, Corp. · Class II
- Actalyke QC Kit - AQC-HP — Helena Laboratories, Corp. · Class II
- i-STAT — Abbott Point of Care Inc. · Class II
- i-STAT — Abbott Point of Care Inc. · Class II
- Hemotec Whole Blood Control Kit Small — Analytical Control Systems
- Hemotec Whole Blood Control Kit Large — Analytical Control Systems
- Hemotec Whole Blood Control Kit Large — Analytical Control Systems · Class II
- Whole Blood Control Level I — Analytical Control Systems · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Analytical Control Systems
Sources (1)
- FDA UDI a9d41b2f-02a8-4ad8-b5f4-326f4a53be2d 34 fields · synced May 31, 2026