IMMULITE® Systems PAP Calibration Verification Material PAP

FDA UDI

Class I (US FDA UDI)

by Siemens Healthcare Diagnostics Products Ltd

Identity

Trade Name: IMMULITE® Systems PAP Calibration Verification Material PAP FDA UDI
Generic Name: Prostatic acid phosphatase (PAP) IVD, control FDA UDI
Device Name: PAP CVM - IMMULITE - CONS FDA UDI
Model / Reference: 10373699 FDA UDI
Description: PAP CVM - IMMULITE - CONS FDA UDI

Identifiers

Catalog Number: LPACVM FDA UDI
Primary DI / UDI-DI: 00630414971315 FDA UDI
510(k) Number: K143373 FDA UDI
FDA Product Code: JJX FDA UDI
GMDN Term: Prostatic acid phosphatase (PAP) 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Prostatic acid phosphatase (PAP) IVD, control

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

Similar devices

Also classified as Prostatic acid phosphatase (PAP) IVD, control.

AIA-PACK PAP CALIBRATION VERIFICATION TEST SET — Tosoh Corp. · Class I
PSAP Control Slides — BIO SB, INC. · Class I
PSAP Control Slides — BIO SB, INC. · Class I
IMMULITE® Systems PAP CONTROL PAP — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II

Cleared under the same submission

K143373 also covers:

IMMULITE® Systems CAL Calibration Verification Material Calcitonin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Siemens Healthcare Diagnostics Products Ltd

Sources (1)

FDA UDI 6544c262-8987-4e29-a2a4-0f211657f090 37 fields · synced May 30, 2026