Identity
- Trade Name
- i-STAT PTplus Control Level 2 FDA UDI
- Generic Name
- Prothrombin time (PT) IVD, control FDA UDI
- Device Name
- For use with i-STAT PTplus cartridges FDA UDI
- Model / Reference
- 06P17-18 FDA UDI
- Description
- For use with i-STAT PTplus cartridges FDA UDI
Identifiers
- Catalog Number
- 06P17-18 FDA UDI
- Primary DI / UDI-DI
- 00054749004850 FDA UDI
- 510(k) Number
- K220282 FDA UDI
- FDA Product Code
- GJS FDA UDI
- GMDN Term
- Prothrombin time (PT) IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7750 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
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: Prothrombin time (PT) IVD, control
i-STAT PTplus Control Level 2 by Abbott Point of Care Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Prothrombin time (PT) IVD, control.
- CRYOcheck™ Abnormal 2 Control — Precision Biologic · Class II
- George King Coumadin® Plasma — GEORGE KING BIO-MEDICAL, INC. · Class II
- QuikCoag Control Level 3 High Abnormal — Biomedica Diagnostics Inc · Class II
- Xprecia™ System PT Controls — Siemens Healthcare Diagnostics · Class II
- George King Coumadin® Plasma — GEORGE KING BIO-MEDICAL, INC. · Class II
- CRYOcheck™ Abnormal 1 Control — Precision Biologic · Class II
- QuikCoag Control Level 2 Low Abnormal — Biomedica Diagnostics Inc · Class II
- George King Coumadin® Plasma — GEORGE KING BIO-MEDICAL, INC. · Class II
Cleared under the same submission
K220282 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 539828e4-0eeb-4a25-83c4-4bdf29d2f1fa 37 fields · synced Jun 9, 2026