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No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

Diazyme Laboratories, Inc.

SRN US-MF-000025166

manufacturer · Poway, US · 53 devices

12889 Gregg Court, 92064

Devices

NameUDI-DIClassBadge
Human Kappa (κ) Free Light Chain Assay00817089023499Class C
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

Human Lambda (λ) Free Light Chain Assay00817089023529Class C
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

Kappa-Lambda FLC Control Set00817089023024Class C
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

Kappa Lambda FLC Control Set (2x 3ml)00817089023512Class C
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

KFLC (cobas c systems)00817089022966Class C
No Certificate Found

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KFLC (cobas c systems)00817089022973Class C
No Certificate Found

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KFLC (cobas c systems)00817089022980Class C
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

LFLC (cobas c systems)00817089022997Class C
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

LFLC (cobas c systems)00817089023000Class C
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

LFLC (cobas c systems)00817089023017Class C
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

Lipoprotein (a) Molarity Assay00817089024311Class B
No Certificate Found

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Lipoprotein (a) Molarity Assay00817089024465Class B
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

Lipoprotein (a) Molarity Assay Calibrator Set00817089024328Class B
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

Lipoprotein (a) Molarity Assay Control Set00817089024335Class B
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

Lipoprotein (a) PCh Molarity Calibrator00817089024564Class B
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

Lipoprotein (a) PCh Molarity Control00817089024571Class B
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

Lipoprotein-Associated Phospholipase A200817089021433Class C
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

LPAPM Lipoprotein (a) Molarity PCh Assay00817089024533Class B
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

LPAPM Lipoprotein (a) Molarity PCh Assay00817089024540Class B
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

LPAPM Lipoprotein (a) Molarity PCh Assay00817089024557Class B
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

Lp-PLA2 Activity Test Calibrators00817089023222Class C
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

Lp-PLA2 Activity Test Controls00817089023239Class C
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

β-Hydroxybutyrate Assay00817089023819Class B
No Certificate Found

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β-Hydroxybutyrate (BHB) Assay00817089023147Class B
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

β-Hydroxybutyrate (BHB) Calibrator Kit00817089023161Class B
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED