Identity
- Trade Name
- i-STAT FDA UDI
- Generic Name
- Activated clotting time (ACT) IVD, kit, clotting FDA UDI
- Device Name
- Kaolin ACT CARTRIDGE FDA UDI
- Model / Reference
- 03P87-25 FDA UDI
- Description
- Kaolin ACT CARTRIDGE FDA UDI
Identifiers
- Catalog Number
- 03P87-25 FDA UDI
- Primary DI / UDI-DI
- 10054749000156 FDA UDI
- 510(k) Number
- K023582 FDA UDI
- FDA Product Code
- JBP FDA UDI
- GMDN Term
- Activated clotting time (ACT) IVD, kit, clotting FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7140 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
Yes
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
No
FDA UDI
Category: Activated clotting time (ACT) IVD, kit, clotting
i-STAT by Abbott Point of Care Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Activated clotting time (ACT) IVD, kit, clotting.
- i-STAT — Abbott Point of Care Inc. · 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 | Class II | Pending data |
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Manufacturer
- Manufacturer
- Abbott Point of Care Inc.
Sources (1)
- FDA UDI 5e6ca8e1-2af0-4474-9f69-07d0e41c66f5 37 fields · synced Jun 9, 2026