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Regulatory and Claim Status

Country selected: US. Claims are bound to smartphone-only inferred CBC outputs, intended use, and region.

Label generated from smartphone-only inferred CBC fields. Confirmatory testing required for treatment decisions.

test-hb

Smartphone-only inferred output. Intended for early diagnostic labeling and clinical decision support within stated operating conditions.

Smartphone-only inferred output. Intended use and evidence tier are region-dependent and must be interpreted with confirmatory pathways.

Intended use: Early disease risk labeling from inferred CBC-style fields, with confirmatory testing required for treatment decisions.

Label generated from smartphone-only inferred CBC fields. Confirmatory testing required for treatment decisions.

test-hct

Smartphone-only inferred output. Intended for early diagnostic labeling and clinical decision support within stated operating conditions.

Smartphone-only inferred output. Intended use and evidence tier are region-dependent and must be interpreted with confirmatory pathways.

Intended use: Early disease risk labeling from inferred CBC-style fields, with confirmatory testing required for treatment decisions.

Label generated from smartphone-only inferred CBC fields. Confirmatory testing required for treatment decisions.

test-rbc

Smartphone-only inferred output. Intended for early diagnostic labeling and clinical decision support within stated operating conditions.

Smartphone-only inferred output. Intended use and evidence tier are region-dependent and must be interpreted with confirmatory pathways.

Intended use: Early disease risk labeling from inferred CBC-style fields, with confirmatory testing required for treatment decisions.

Label generated from smartphone-only inferred CBC fields. Confirmatory testing required for treatment decisions.

test-mcv

Smartphone-only inferred output. Intended for early diagnostic labeling and clinical decision support within stated operating conditions.

Smartphone-only inferred output. Intended use and evidence tier are region-dependent and must be interpreted with confirmatory pathways.

Intended use: Early disease risk labeling from inferred CBC-style fields, with confirmatory testing required for treatment decisions.

Label generated from smartphone-only inferred CBC fields. Confirmatory testing required for treatment decisions.

test-mch

Smartphone-only inferred output. Intended for early diagnostic labeling and clinical decision support within stated operating conditions.

Smartphone-only inferred output. Intended use and evidence tier are region-dependent and must be interpreted with confirmatory pathways.

Intended use: Early disease risk labeling from inferred CBC-style fields, with confirmatory testing required for treatment decisions.

Label generated from smartphone-only inferred CBC fields. Confirmatory testing required for treatment decisions.

test-mchc

Smartphone-only inferred output. Intended for early diagnostic labeling and clinical decision support within stated operating conditions.

Smartphone-only inferred output. Intended use and evidence tier are region-dependent and must be interpreted with confirmatory pathways.

Intended use: Early disease risk labeling from inferred CBC-style fields, with confirmatory testing required for treatment decisions.

Label generated from smartphone-only inferred CBC fields. Confirmatory testing required for treatment decisions.

test-rdw

Smartphone-only inferred output. Intended for early diagnostic labeling and clinical decision support within stated operating conditions.

Smartphone-only inferred output. Intended use and evidence tier are region-dependent and must be interpreted with confirmatory pathways.

Intended use: Early disease risk labeling from inferred CBC-style fields, with confirmatory testing required for treatment decisions.

Label generated from smartphone-only inferred CBC fields. Confirmatory testing required for treatment decisions.

test-wbc-total

Smartphone-only inferred output. Intended for early diagnostic labeling and clinical decision support within stated operating conditions.

Smartphone-only inferred output. Intended use and evidence tier are region-dependent and must be interpreted with confirmatory pathways.

Intended use: Early disease risk labeling from inferred CBC-style fields, with confirmatory testing required for treatment decisions.

Label generated from smartphone-only inferred CBC fields. Confirmatory testing required for treatment decisions.