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Ihc

FDA UDI

Class I (US FDA UDI)

by Slmp, LLC

Identity

Trade Name
IHC FDA UDI
Generic Name
Free (unbound) prostate specific antigen (fPSA) IVD, antibody FDA UDI
Device Name
PSA (Prostate Specific Antigen), Clone 3H59, 10ml FDA UDI
Model / Reference
(BTO) RTU PSA Prostate Specific Antigen (3H59) Antibody (10ml) FDA UDI
Description
PSA (Prostate Specific Antigen), Clone 3H59, 10ml FDA UDI

Identifiers

Catalog Number
MM130-10 FDA UDI
Primary DI / UDI-DI
00810170550584 FDA UDI
FDA Product Code
NJT FDA UDI
GMDN Term
Free (unbound) prostate specific antigen (fPSA) 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

Yes

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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Free (unbound) prostate specific antigen (fPSA) IVD, antibody

Ihc by Slmp, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Free (unbound) prostate specific antigen (fPSA) IVD, antibody.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Slmp, LLC

Sources (1)

  • FDA UDI cb151f46-3dd8-45f6-a2ec-560ce0b5c25b 34 fields · synced May 30, 2026