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Platelet Aggregation Kit

FDA UDI

Class II (US FDA UDI)

by Helena Laboratories, Corp.

Identity

Trade Name
Platelet Aggregation Kit FDA UDI
Generic Name
Platelet aggregation study IVD, reagent FDA UDI
Model / Reference
5369 FDA UDI

Identifiers

Primary DI / UDI-DI
M52553690 FDA UDI
510(k) Number
K832428 FDA UDI
FDA Product Code
GHR 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

Platelet Aggregation Kit by Helena Laboratories, Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Platelet aggregation study IVD, reagent.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Helena Laboratories, Corp.

Sources (1)

  • FDA UDI 81354c5d-2626-4421-9e80-ed27d6cad727 34 fields · synced Jun 9, 2026