Identity
- Trade Name
- Hemotec Whole Blood Control Kit Small FDA UDI
- Generic Name
- Activated clotting time (ACT) IVD, control FDA UDI
- Device Name
- Whole Blood Control Kit containing 2 vials of each: SC-125, SC-126, and DW-10 FDA UDI
- Model / Reference
- WBC-HT-101 FDA UDI
- Description
- Whole Blood Control Kit containing 2 vials of each: SC-125, SC-126, and DW-10 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817869020342 FDA UDI
- GMDN Term
- Activated clotting time (ACT) IVD, control FDA UDI
Classification
- 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
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
Hemotec Whole Blood Control Kit Small by Analytical Control Systems — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Activated clotting time (ACT) IVD, control.
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- i-STAT — Abbott Point of Care Inc. · Class II
- i-STAT — Abbott Point of Care Inc. · Class II
- 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
- Whole Blood Control Level III — Analytical Control Systems · Class II
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
- Analytical Control Systems
Sources (1)
- FDA UDI c08b2627-0982-4596-8b6a-56f411c8e59a 33 fields · synced Jun 8, 2026