Identity
- Trade Name
- PL Chip FDA UDI
- Generic Name
- Platelet aggregation study IVD, reagent FDA UDI
- Device Name
- Flow chamber microchip used to measure platelet thrombus formation (primary hemostatic function) FDA UDI
- Model / Reference
- N/A FDA UDI
- Description
- Flow chamber microchip used to measure platelet thrombus formation (primary hemostatic function) FDA UDI
Identifiers
- Catalog Number
- 18002 FDA UDI
- Primary DI / UDI-DI
- 04589448510082 FDA UDI
- 510(k) Number
- K191364 FDA UDI
- FDA Product Code
- JOZ FDA UDI
- GMDN Term
- Platelet aggregation study IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.5700 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
Yes
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: Platelet aggregation study IVD, reagent
PL Chip by Zacros Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K191364 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
- Zacros Corporation
Sources (1)
- FDA UDI c89d9efa-201a-4d0a-acc4-4543b8f3e8d1 35 fields · synced May 30, 2026