LeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare Ultra kit is provided with the following materials: "Sensors (8 containers of 24 each; 192 tests) "Treatment Reagent Tubes (8 containers of 24 each; 192 tests) "Calibration Button (1 @) "Lead Control Level 1 (1 @ 2 mL) "Lead Control Level 2 (1 @ 2 mL) (UDI Z-1895-2026)
Manufactured by Magellan Diagnostics, Inc.
Device Regulatory Overview
The LeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare Ultra kit is provided with the following materials: "Sensors (8 containers of 24 each; 192 tests) "Treatment Reagent Tubes (8 containers of 24 each; 192 tests) "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: 70-8098; UDI-DI: 00850355006024; ALL lots and ALL sublots; within international Unique Device Identification (UDI) compliance databases.
Enforcement actions are currently active for this product line.
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Technical Specifications
- Model Number
- N/A
- Product Code / EMDN
- Catalog Number: 70-8098; UDI-DI: 00850355006024; ALL lots and ALL sublots;
- Device Name
- LeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare Ultra kit is provided with the following materials: "Sensors (8 containers of 24 each; 192 tests) "Treatment Reagent Tubes (8 containers of 24 each; 192 tests) "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
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of LeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare Ultra kit is provided with the following materials: "Sensors (8 containers of 24 each; 192 tests) "Treatment Reagent Tubes (8 containers of 24 each; 192 tests) "Calibration Button (1 @) "Lead Control Level 1 (1 @ 2 mL) "Lead Control Level 2 (1 @ 2 mL)?
The registered manufacturer of record for LeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare Ultra kit is provided with the following materials: "Sensors (8 containers of 24 each; 192 tests) "Treatment Reagent Tubes (8 containers of 24 each; 192 tests) "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 LeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare Ultra kit is provided with the following materials: "Sensors (8 containers of 24 each; 192 tests) "Treatment Reagent Tubes (8 containers of 24 each; 192 tests) "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-1895-2026.
What classification code is assigned to this device?
This device is registered under product classification code Catalog Number: 70-8098; UDI-DI: 00850355006024; ALL lots and ALL sublots;.
Other Devices by Magellan Diagnostics, Inc.
- → (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)
- → LeadCare Plus Blood Lead Test Kit; Catalog Number: 82-0004; The LeadCare Plus kit is provided with the following materials: "Sensors (4 containers of 24 each; 96 tests) "Treatment Reagent Tubes (4 packages of 24 each; 96 tests) "Calibration Button (1 @) "Lead Control Level 1 (1 @ 2 mL) "Lead Control Level 2 (1 @ 2 mL)
- → The LeadCare II Blood Lead Test System relies on electrochemistry and a unique Sensor to detect lead in whole blood. The LeadCare II Test 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)
- → LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only. The test kit is for the quantitative measurement of lead in capillary whole blood.
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