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FREND PSA Plus

FDA UDI

Class II (US FDA UDI)

by NanoEnTek, Inc.

Identity

Trade Name
FREND PSA Plus FDA UDI
Generic Name
Total prostate specific antigen (tPSA) IVD, kit, fluorescent immunoassay FDA UDI
Device Name
It is used for the quantitiative determination of Prostate Specific Antigen(PSA) in human specimen using FREND System. FDA UDI
Model / Reference
FRPS 025 FDA UDI
Description
It is used for the quantitiative determination of Prostate Specific Antigen(PSA) in human specimen using FREND System. FDA UDI

Identifiers

Catalog Number
FRPS 025 FDA UDI
Primary DI / UDI-DI
08809317540184 FDA UDI
510(k) Number
K124056 FDA UDI
FDA Product Code
LTJ FDA UDI
GMDN Term
Total prostate specific antigen (tPSA) IVD, kit, fluorescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.6010 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

Yes

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: Total prostate specific antigen (tPSA) IVD, kit, fluorescent immunoassay

FREND PSA Plus by NanoEnTek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Total prostate specific antigen (tPSA) IVD, kit, fluorescent immunoassay.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
NanoEnTek, Inc.

Sources (1)

  • FDA UDI 1b7b889c-90ab-4885-91ce-568b183609b4 35 fields · synced May 30, 2026