Identity
- Trade Name
- i-STAT PTplus Cartridge FDA UDI
- Generic Name
- Prothrombin time (PT) IVD, kit, clotting FDA UDI
- Device Name
- For the determination of prothrombin time. FDA UDI
- Model / Reference
- 03P89-50 FDA UDI
- Description
- For the determination of prothrombin time. FDA UDI
Identifiers
- Catalog Number
- 03P89-50 FDA UDI
- Primary DI / UDI-DI
- 00054749004782 FDA UDI
- 510(k) Number
- K220282 FDA UDI
- FDA Product Code
- GJS FDA UDI
- GMDN Term
- Prothrombin time (PT) IVD, kit, clotting 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
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
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, kit, clotting
i-STAT PTplus Cartridge 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
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 2f4239d6-24ac-4668-9bd6-1e3d7769a1b2 37 fields · synced Jun 9, 2026