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Dade® Cluster® Platelet Aggregation Reagents

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics Products Ltd

Identity

Trade Name
Dade® Cluster® Platelet Aggregation Reagents FDA UDI
Generic Name
Platelet aggregation study IVD, kit, nephelometry/turbidimetry FDA UDI
Device Name
For use in platelet aggregometry studies FDA UDI
Model / Reference
10445725 FDA UDI
Description
For use in platelet aggregometry studies FDA UDI

Identifiers

Catalog Number
B4236-1 FDA UDI
Primary DI / UDI-DI
00842768003998 FDA UDI
510(k) Number
K780047 FDA UDI
FDA Product Code
JOZ FDA UDI
GMDN Term
Platelet aggregation study IVD, kit, nephelometry/turbidimetry 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, kit, nephelometry/turbidimetry

Dade® Cluster® Platelet Aggregation Reagents by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Platelet aggregation study IVD, kit, nephelometry/turbidimetry.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Siemens Healthcare Diagnostics Products Ltd

Sources (1)

  • FDA UDI 8d8bcda2-4876-4f81-b03f-a2df018adc00 37 fields · synced May 30, 2026