pma Primary ID: P010007

IMMULITE/IMMULITE 1000 AFP AND IMMULITE 2000/IMMULITE 2500 AFP (UDI P010007)

Manufactured by Siemens Healthcare Diagnostics, Inc.

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The IMMULITE/IMMULITE 1000 AFP AND IMMULITE 2000/IMMULITE 2500 AFP (Model/Catalog Number: Unspecified) is a medical device manufactured by Siemens Healthcare Diagnostics, Inc.. This product is indexed under FDA Product Code / Category Classification LOK within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 3 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-2703-2026 View Full Alert →

Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536....

🔒 Compromised Lot & Serial Numbers Locked

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ID: Z-2398-2026 View Full Alert →

Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay...

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ID: Z-1980-2026 View Full Alert →

Dimension Creatinine Flex reagent cartridge. Material Number: 10872079....

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Technical Specifications

Model Number: N/A
Product Code / EMDN: LOK
Device Name: KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
Database Sync Date: 2026-08-09 10:04:45

Full Regulatory Attributes

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{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

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Frequently Asked Questions

Who is the primary manufacturer of IMMULITE/IMMULITE 1000 AFP AND IMMULITE 2000/IMMULITE 2500 AFP?

The registered manufacturer of record for IMMULITE/IMMULITE 1000 AFP AND IMMULITE 2000/IMMULITE 2500 AFP is Siemens Healthcare Diagnostics, Inc..

What is the Primary UDI-DI identifier for IMMULITE/IMMULITE 1000 AFP AND IMMULITE 2000/IMMULITE 2500 AFP?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is P010007.

What classification code is assigned to this device?

This device is registered under product classification code LOK.

Similar Classification Devices (LOK)

Other Devices by Siemens Healthcare Diagnostics, Inc.

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