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AggRAM Module (Domestic)

FDA UDI

Class II (US FDA UDI)

by Helena Laboratories, Corp.

Identity

Trade Name
AggRAM Module (Domestic) FDA UDI
Generic Name
Platelet aggregation analyser IVD FDA UDI
Model / Reference
8JF52001 FDA UDI

Identifiers

Primary DI / UDI-DI
M5258JF520010 FDA UDI
510(k) Number
K050053 FDA UDI
FDA Product Code
JPA FDA UDI
GMDN Term
Platelet aggregation analyser IVD FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.5425 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

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Platelet aggregation analyser IVD

AggRAM Module (Domestic) by Helena Laboratories, Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Platelet aggregation analyser IVD.

Cleared under the same submission

K050053 also covers:

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 c5c9a7db-e5ff-4716-af73-f432ccf7b682 34 fields · synced Jun 9, 2026