Identity
- Trade Name
- Dade® PFA Trigger Solution FDA UDI
- Generic Name
- Platelet aggregation study IVD, reagent FDA UDI
- Device Name
- To aid in the detection of platelet dysfunction in citrated human whole blood FDA UDI
- Model / Reference
- 10445701 FDA UDI
- Description
- To aid in the detection of platelet dysfunction in citrated human whole blood FDA UDI
Identifiers
- Catalog Number
- B4170-50 FDA UDI
- Primary DI / UDI-DI
- 00842768003691 FDA UDI
- 510(k) Number
- K060489 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
No
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: Platelet aggregation study IVD, reagent
Dade® PFA Trigger Solution by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Platelet aggregation study IVD, reagent.
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- TEG HEMOSTASIS SYSTEM — HAEMONETICS CORPORATION · Class II
Cleared under the same submission
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
- Siemens Healthcare Diagnostics Products Ltd
Sources (1)
- FDA UDI be8e5fc1-34d5-40de-b210-5be8fd9db5f8 37 fields · synced May 31, 2026