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Prostate Specific Antigen (PSA)

FDA UDI

Class I (US FDA UDI)

by Biocare Medical, Llc

Identity

Trade Name
Prostate Specific Antigen (PSA) FDA UDI
Generic Name
Tissue prostate specific antigen (PSA) IVD, antibody FDA UDI
Model / Reference
NPAI390T40 FDA UDI

Identifiers

Primary DI / UDI-DI
00847627039804 FDA UDI
FDA Product Code
NJT FDA UDI
GMDN Term
Tissue prostate specific antigen (PSA) IVD, antibody FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.1860 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

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Tissue prostate specific antigen (PSA) IVD, antibody

Prostate Specific Antigen (PSA) by Biocare Medical, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Tissue prostate specific antigen (PSA) IVD, antibody.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biocare Medical, Llc

Sources (1)

  • FDA UDI 4bacdf5d-65dc-4964-8e2b-8f6fc1ae963e 33 fields · synced May 30, 2026