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IMMULITE® Systems PTS Calibration Verification Material PSA

FDA UDI

Class I (US FDA UDI)

by Siemens Healthcare Diagnostics Products Ltd

Identity

Trade Name
IMMULITE® Systems PTS Calibration Verification Material PSA FDA UDI
Generic Name
Complexed prostate specific antigen (cPSA) IVD, control FDA UDI
Device Name
PSA CVM - IMMULITE – CONS FDA UDI
Model / Reference
10713726 FDA UDI
Description
PSA CVM - IMMULITE – CONS FDA UDI

Identifiers

Catalog Number
LPTSCVM FDA UDI
Primary DI / UDI-DI
00630414601946 FDA UDI
510(k) Number
K131536 FDA UDI
FDA Product Code
JJX FDA UDI
GMDN Term
Complexed prostate specific antigen (cPSA) 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: Complexed prostate specific antigen (cPSA) IVD, control

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

Similar devices

Also classified as Complexed prostate specific antigen (cPSA) 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 22e6ec20-eaa8-47a1-86db-fb64e5c48635 37 fields · synced May 30, 2026