GUDIDData
Bulk Audit Tool API Access
enforcement Primary ID: Z-1893-2026

(1)(2) LeadCare II Blood Lead Test Kit, (3)LeadCare II 5X Blood Lead Test Kit, (4)LeadCare II 9X Blood Lead Test Kit ; Catalog Number(s): (1) 70-6762, (2) 70-6762RUO, (3) 70-8404 (Box containing 5 Test Kits), (4) 70-9000 (Box containing 9 test kits); The LeadCare II kit is provided with the following materials: "Sensors (2 Containers of 24 sensors each; 48 tests) "Treatment Reagent Tubes (2 packages of 24 tubes each; 48 tests) "Heparinized Capillary Tubes/Plungers (50 @) "Transfer Droppers (50 @) "Calibration Button (1 @) "Lead Control Level 1 (1 @ 2 mL) "Lead Control Level 2 (1 @ 2 mL) (UDI Z-1893-2026)

Manufactured by Magellan Diagnostics, Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for (1)(2) LeadCare II Blood Lead Test Kit, (3)LeadCare II 5X Blood Lead Test Kit, (4)LeadCare II 9X Blood Lead Test Kit ; Catalog Number(s): (1) 70-6762, (2) 70-6762RUO, (3) 70-8404 (Box containing 5 Test Kits), (4) 70-9000 (Box containing 9 test kits); The LeadCare II kit is provided with the following materials: "Sensors (2 Containers of 24 sensors each; 48 tests) "Treatment Reagent Tubes (2 packages of 24 tubes each; 48 tests) "Heparinized Capillary Tubes/Plungers (50 @) "Transfer Droppers (50 @) "Calibration Button (1 @) "Lead Control Level 1 (1 @ 2 mL) "Lead Control Level 2 (1 @ 2 mL) - Primary ID Z-1893-2026

Device Regulatory Overview

The (1)(2) LeadCare II Blood Lead Test Kit, (3)LeadCare II 5X Blood Lead Test Kit, (4)LeadCare II 9X Blood Lead Test Kit ; Catalog Number(s): (1) 70-6762, (2) 70-6762RUO, (3) 70-8404 (Box containing 5 Test Kits), (4) 70-9000 (Box containing 9 test kits); The LeadCare II kit is provided with the following materials: "Sensors (2 Containers of 24 sensors each; 48 tests) "Treatment Reagent Tubes (2 packages of 24 tubes each; 48 tests) "Heparinized Capillary Tubes/Plungers (50 @) "Transfer Droppers (50 @) "Calibration Button (1 @) "Lead Control Level 1 (1 @ 2 mL) "Lead Control Level 2 (1 @ 2 mL) (Model/Catalog Number: Unspecified) is a medical device manufactured by Magellan Diagnostics, Inc.. This product is indexed under FDA Product Code / Category Classification Catalog Number(s): (1) 70-6762, (2) 70-6762RUO; UDI-DI: 00850355006000; ALL lots and ALL sublots; Catalog Number(s): (3) 70-8404; UDI-DI: 00850355006086; ALL lots and ALL sublots; Catalog Number(s): (4) 70-9000; UDI-DI: 00850355006093; ALL lots and ALL sublots; 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-2753-2026 View Full Alert →

FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)
ID: Z-2755-2026 View Full Alert →

FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21M402, I...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)
ID: Z-2793-2026 View Full Alert →

SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)

Technical Specifications

Model Number
N/A
Device Name
(1)(2) LeadCare II Blood Lead Test Kit, (3)LeadCare II 5X Blood Lead Test Kit, (4)LeadCare II 9X Blood Lead Test Kit ; Catalog Number(s): (1) 70-6762, (2) 70-6762RUO, (3) 70-8404 (Box containing 5 Test Kits), (4) 70-9000 (Box containing 9 test kits); The LeadCare II kit is provided with the following materials: "Sensors (2 Containers of 24 sensors each; 48 tests) "Treatment Reagent Tubes (2 packages of 24 tubes each; 48 tests) "Heparinized Capillary Tubes/Plungers (50 @) "Transfer Droppers (50 @) "Calibration Button (1 @) "Lead Control Level 1 (1 @ 2 mL) "Lead Control Level 2 (1 @ 2 mL)
Database Sync Date
2026-08-09 10:06:32

Full Regulatory Attributes

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

Unlock Compliance Data & Serialization Specs

Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.

Get API Token Access ($49/mo)

Frequently Asked Questions

Who is the primary manufacturer of (1)(2) LeadCare II Blood Lead Test Kit, (3)LeadCare II 5X Blood Lead Test Kit, (4)LeadCare II 9X Blood Lead Test Kit ; Catalog Number(s): (1) 70-6762, (2) 70-6762RUO, (3) 70-8404 (Box containing 5 Test Kits), (4) 70-9000 (Box containing 9 test kits); The LeadCare II kit is provided with the following materials: "Sensors (2 Containers of 24 sensors each; 48 tests) "Treatment Reagent Tubes (2 packages of 24 tubes each; 48 tests) "Heparinized Capillary Tubes/Plungers (50 @) "Transfer Droppers (50 @) "Calibration Button (1 @) "Lead Control Level 1 (1 @ 2 mL) "Lead Control Level 2 (1 @ 2 mL)?

The registered manufacturer of record for (1)(2) LeadCare II Blood Lead Test Kit, (3)LeadCare II 5X Blood Lead Test Kit, (4)LeadCare II 9X Blood Lead Test Kit ; Catalog Number(s): (1) 70-6762, (2) 70-6762RUO, (3) 70-8404 (Box containing 5 Test Kits), (4) 70-9000 (Box containing 9 test kits); The LeadCare II kit is provided with the following materials: "Sensors (2 Containers of 24 sensors each; 48 tests) "Treatment Reagent Tubes (2 packages of 24 tubes each; 48 tests) "Heparinized Capillary Tubes/Plungers (50 @) "Transfer Droppers (50 @) "Calibration Button (1 @) "Lead Control Level 1 (1 @ 2 mL) "Lead Control Level 2 (1 @ 2 mL) is Magellan Diagnostics, Inc..

What is the Primary UDI-DI identifier for (1)(2) LeadCare II Blood Lead Test Kit, (3)LeadCare II 5X Blood Lead Test Kit, (4)LeadCare II 9X Blood Lead Test Kit ; Catalog Number(s): (1) 70-6762, (2) 70-6762RUO, (3) 70-8404 (Box containing 5 Test Kits), (4) 70-9000 (Box containing 9 test kits); The LeadCare II kit is provided with the following materials: "Sensors (2 Containers of 24 sensors each; 48 tests) "Treatment Reagent Tubes (2 packages of 24 tubes each; 48 tests) "Heparinized Capillary Tubes/Plungers (50 @) "Transfer Droppers (50 @) "Calibration Button (1 @) "Lead Control Level 1 (1 @ 2 mL) "Lead Control Level 2 (1 @ 2 mL)?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Z-1893-2026.

What classification code is assigned to this device?

This device is registered under product classification code Catalog Number(s): (1) 70-6762, (2) 70-6762RUO; UDI-DI: 00850355006000; ALL lots and ALL sublots; Catalog Number(s): (3) 70-8404; UDI-DI: 00850355006086; ALL lots and ALL sublots; Catalog Number(s): (4) 70-9000; UDI-DI: 00850355006093; ALL lots and ALL sublots;.

Other Devices by Magellan Diagnostics, Inc.

Programmatic Export

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

JSON API Endpoint