- CLIA-waived LeadCare II blood lead test kit for quantitative measurement of lead in whole blood using the LeadCare II Analyzer.
- Delivers accurate results in about 3 minutes from a 50 µL (two-drop) capillary or venous whole blood sample obtained by fingerstick.
- Each 48-test kit includes sensors, treatment reagent tubes, capillaries with plungers, transfer droppers, two levels of quality control and a calibration button.
- Supports point-of-care screening and monitoring for children and adults in clinics, community programs and occupational health settings.
- SKU:
- 915306
- Contents:
- (48) Sensors, (48) Tubes of Treatment Reagent, (50) Capillary and Plungers, (50) Transfer Droppers, Calibration Button, (2) Levels Control Solution
- For Use With:
- For LeadCare II Analyzer
- QTY Per Sell:
- 1
- GTIN:
- 00850355006000
- Number of Tests:
- 48 Tests
- Reading Type:
- Machine Read
- Sample Type:
- Whole Blood Sample
- Key Features:
- CLIA-waived point-of-care system
- Quantitative whole blood lead measurement
- Results in about 3 minutes
- Portable, simple operation
- Technical Specifications:
- Sample: capillary whole blood (EDTA or heparin)
- Sample volume: 50 µL (~2 drops)
- Reportable range: 3.3–65 µg/dL
- Test time: ~3 minutes
- Regulatory Information:
- FDA 510(k)-cleared (K052549) quantitative in vitro diagnostic device; CLIA complexity: waived; for professional use only.
- Clinical Applications:
- Pediatric blood lead screening
- Pregnancy and adult monitoring
- Occupational and public health testing
- Packaging Details:
- 48 tests per box; includes sensors, treatment reagent tubes, capillaries with plungers, transfer droppers, two-level controls and calibration button.
- Usage Instructions:
- Collect 50 µL whole blood, mix with treatment reagent, apply mixture to sensor in LeadCare II Analyzer and follow the current package insert.
- Warnings and Precautions:
- For in vitro diagnostic use only. Use only with LeadCare II Analyzer. Review current Magellan/Meridian recall and field action notices and do not use expired kits.
- Codes and Identifiers:
- Catalog number: 70-6762
- UDI-DI: (01)00850355006000
- CPT code: 83655 (QW modifier as applicable)
- CLIA complexity: waived
- Manufacturer:
- Manufactured by Magellan Diagnostics, a Meridian Bioscience company.
- Shelf Life:
- Shelf life currently 9 months from date of manufacture; calibration button prevents use past kit expiration date on box label.
- SKU:
- 915306
- Contents:
- (48) Sensors, (48) Tubes of Treatment Reagent, (50) Capillary and Plungers, (50) Transfer Droppers, Calibration Button, (2) Levels Control Solution
- For Use With:
- For LeadCare II Analyzer
- QTY Per Sell:
- 1
- GTIN:
- 00850355006000
- Number of Tests:
- 48 Tests
- Reading Type:
- Machine Read
- Sample Type:
- Whole Blood Sample
- ic__sync_id:
- 1
- ic__id:
- 1271
- Key Features:
- CLIA-waived point-of-care system
- Quantitative whole blood lead measurement
- Results in about 3 minutes
- Portable, simple operation
- Technical Specifications:
- Sample: capillary whole blood (EDTA or heparin)
- Sample volume: 50 µL (~2 drops)
- Reportable range: 3.3–65 µg/dL
- Test time: ~3 minutes
- Regulatory Information:
- FDA 510(k)-cleared (K052549) quantitative in vitro diagnostic device; CLIA complexity: waived; for professional use only.
- Clinical Applications:
- Pediatric blood lead screening
- Pregnancy and adult monitoring
- Occupational and public health testing
- Packaging Details:
- 48 tests per box; includes sensors, treatment reagent tubes, capillaries with plungers, transfer droppers, two-level controls and calibration button.
- Usage Instructions:
- Collect 50 µL whole blood, mix with treatment reagent, apply mixture to sensor in LeadCare II Analyzer and follow the current package insert.
- Warnings and Precautions:
- For in vitro diagnostic use only. Use only with LeadCare II Analyzer. Review current Magellan/Meridian recall and field action notices and do not use expired kits.
- Codes and Identifiers:
- Catalog number: 70-6762
- UDI-DI: (01)00850355006000
- CPT code: 83655 (QW modifier as applicable)
- CLIA complexity: waived
- Manufacturer:
- Manufactured by Magellan Diagnostics, a Meridian Bioscience company.
- Shelf Life:
- Shelf life currently 9 months from date of manufacture; calibration button prevents use past kit expiration date on box label.
