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Magellan Diagnostics, Inc. Registered Devices

Listing registered devices, PMA filings, and compliance records for Magellan Diagnostics, Inc..

enforcement (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) ID: Z-1893-2026
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enforcement 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) ID: Z-1894-2026
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enforcement 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) ID: Z-1895-2026
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enforcement 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) ID: Z-0584-2026
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enforcement 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. ID: Z-0219-2024
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enforcement Magellan Diagnostics LeadCare Ultra Blood Analyzer Part Number: 80-0010 ID: Z-1925-2017
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enforcement Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits Part Number: 80-0010 ID: Z-1926-2017
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enforcement Magellan Diagnostics LeadCare and LeadCare II test Kits. Product Usage: The LeadCare Blood Lead Test Kit is for in vitro diagnostic use only. The Test Kit is for the quantitative measurement of lead in fresh whole blood. This product is for professional use only. Sensors and Treatment Reagent of the Test Kit are specific for lead only. Contents of this LeadCare Blood Lead Test Kit must only be used with a LeadCare Analyzer and Blood Lead Testing System. ID: Z-2225-2017
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enforcement Magellan Diagnostics LeadCare Ultra and LeadCare Plus test Kits. Product Usage: The LeadCare Blood Lead Test Kit is for in vitro diagnostic use only. The Test Kit is for the quantitative measurement of lead in fresh whole blood. This product is for professional use only. Sensors and Treatment Reagent of the Test Kit are specific for lead only. Contents of this LeadCare Blood Lead Test Kit must only be used with a LeadCare Analyzer and Blood Lead Testing System. ID: Z-2226-2017
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enforcement LeadCare II Blood Lead Test Kit, containing LeadCare II Lead Controls Product Usage: IVD test kit for the detection of lead in blood. The kit consists of sensors, treatment reagent, lead controls (two levels), heparinized capillary tubes and plungers, transfer droppers and a calibration button. The LeadCare II Lead Controls packaged in the kit lots listed in #2 below are the subject of this recall (Field Correction) action. ID: Z-3035-2017
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enforcement LeadCare Plus Blood Lead Analyzer Part Number: 82-0001 Intended for the quantitative measurement of lead in a whole blood sample. ID: Z-1296-2018
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enforcement LeadCare II Blood Lead Analyzer Part Numbers: 70-6760, 70-6529-R, 70-6760-P, 70-6760-R. Intended for in vitro (external) use only. ID: Z-1295-2018
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enforcement Magellan LeadCare II Blood Lead Test Kit. In Vitro Test for the measurement of lead in fresh whole blood. Catalog Number: 70-6762 Primary DI No: 00850355006000 The LeadCare II Blood Lead Test Kit is for in vitro diagnostic use only. The test kit is for the quantitative measurement of lead in fresh whole blood. This product is for professional use only. Sensors and treatment reagent of the test kit are specific for lead only. Contents of the LeadCare II Blood Lead Test Kit must only be used with a LeadCare II Analyzer. ID: Z-0285-2019
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enforcement LeadCare Plus Blood Lead Test Kit Catalog Number 82-0004 ID: Z-1953-2021
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enforcement LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098 ID: Z-1954-2021
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enforcement LeadCare II Blood Lead Test Kit Catalog Number 70-6762 ID: Z-1952-2021
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