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IMMULITE® Systems fPS Calibration Verification Material Free PSA

FDA UDI

Class I (US FDA UDI)

by Siemens Healthcare Diagnostics Products Ltd

Identity

Trade Name
IMMULITE® Systems fPS Calibration Verification Material Free PSA FDA UDI
Generic Name
Free (unbound) prostate specific antigen (fPSA) IVD, control FDA UDI
Device Name
Free PSA CVM - IMMULITE - CONS FDA UDI
Model / Reference
10373702 FDA UDI
Description
Free PSA CVM - IMMULITE - CONS FDA UDI

Identifiers

Catalog Number
LPFCVM FDA UDI
Primary DI / UDI-DI
00630414971346 FDA UDI
510(k) Number
K133816 FDA UDI
FDA Product Code
JJX FDA UDI
GMDN Term
Free (unbound) prostate specific antigen (fPSA) IVD, control FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1660 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, control

IMMULITE® Systems fPS Calibration Verification Material Free PSA by Siemens Healthcare Diagnostics Products Ltd — Class I — FDA UDI — listed in FDA GUDID

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Siemens Healthcare Diagnostics Products Ltd

Sources (1)

  • FDA UDI 43e5b611-3592-4089-99b5-6142462f35b7 37 fields · synced May 30, 2026