GUDIDData
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pma Primary ID: P010007

IMMULITE/IMMULITE 1000 AFP, IMMULITE 2000 AFP (UDI P010007)

Manufactured by Siemens Healthcare Diagnostics, Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for IMMULITE/IMMULITE 1000 AFP, IMMULITE 2000 AFP - Primary ID P010007

Device Regulatory Overview

The IMMULITE/IMMULITE 1000 AFP, IMMULITE 2000 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...

🔒 Compromised Lot & Serial Numbers Locked
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ID: Z-1980-2026 View Full Alert →

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

🔒 Compromised Lot & Serial Numbers Locked
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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 10:06:17

Full Regulatory Attributes

🔒 Token Gated 
{
    "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, IMMULITE 2000 AFP?

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

What is the Primary UDI-DI identifier for IMMULITE/IMMULITE 1000 AFP, IMMULITE 2000 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.

Programmatic Export

Export this master device record as standardized JSON or CSV for compliance audits.

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