← Back to catalogue

Dimension® clinical chemistry system FPSA Flex® reagent cartridge

FDA UDI

Class III (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
Dimension® clinical chemistry system FPSA Flex® reagent cartridge FDA UDI
Generic Name
Free (unbound) prostate specific antigen (fPSA) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
Heterogeneous Immunoassay Module Free Prostate Specific Antigen Flex® reagent cartridge 120 Test FDA UDI
Model / Reference
10444888 FDA UDI
Description
Heterogeneous Immunoassay Module Free Prostate Specific Antigen Flex® reagent cartridge 120 Test FDA UDI

Identifiers

Catalog Number
RF452 FDA UDI
Primary DI / UDI-DI
00842768013881 FDA UDI
PMA Number
P020027 FDA UDI
FDA Product Code
MTG FDA UDI
GMDN Term
Free (unbound) prostate specific antigen (fPSA) IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class III 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

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: Free (unbound) prostate specific antigen (fPSA) IVD, kit, enzyme immunoassay (EIA)

Dimension® clinical chemistry system FPSA Flex® reagent cartridge by Siemens Healthcare Diagnostics — Class III — FDA UDI — listed in FDA GUDID

Cleared under the same submission

P020027 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Siemens Healthcare Diagnostics

Sources (1)

  • FDA UDI 0cc6a483-3571-4674-8f20-d40d0345ddfd 37 fields · synced May 30, 2026