Identity
- Trade Name
- i-STAT FDA UDI
- Generic Name
- Activated clotting time (ACT) IVD, control FDA UDI
- Device Name
- i-STAT ACT, CONTROL LEVEL 1 FDA UDI
- Model / Reference
- 06P17-15 FDA UDI
- Description
- i-STAT ACT, CONTROL LEVEL 1 FDA UDI
Identifiers
- Catalog Number
- 06P17-15 FDA UDI
- Primary DI / UDI-DI
- 00054749001231 FDA UDI
- 510(k) Number
- K120900 FDA UDI
- FDA Product Code
- GGN 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
No
FDA UDI
Category: Activated clotting time (ACT) IVD, control
i-STAT by Abbott Point of Care Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K120900 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
- Abbott Point of Care Inc.
Sources (1)
- FDA UDI b7c88466-6579-4f39-8011-ca1a2c0a3402 37 fields · synced Jun 9, 2026