Diazyme Laboratories
Diazyme Laboratories holds FDA 510(k) medical device clearances, first cleared 2003, most recent 2018.
Top product codes for Diazyme Laboratories
Recent clearances by Diazyme Laboratories
- K172992 — Diazyme EZ Vitamin D Assay
- K163418 — Diazyme DZ-Lite Total beta-hCG Test System
- K162297 — Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set
- K160762 — Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set
- K153394 — Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay, Diazyme Human Kappa/Lamda Free Light Chain Calibrator, Diazyme Human Kappa/Lamda Free Light Chain Calibrator
- K161646 — Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set
- K161721 — Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set
- K143470 — Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set
- K133803 — DIAZYME GLYCATED SERUM PROTEIN POC TEST KIT
- K133083 — DIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIAZYME FERRITIN CONTROL SET
- K133410 — DIAZYME 25-OH VITAMIN D ASSAY; DIAZYME 25-OH VITAMIN D CONTROL SET
- K131556 — DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SET
- K123785 — DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SET
- K112120 — DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET
- K122420 — DIAZYME 25-HYDROXY VITAMIN D EIA KIT DIAZYME 25-HYDROXY VITAMIN D EIA CONTROL SET DIA
- K121558 — DIAZYME HSCRP POC TEST KIT
- K121053 — DIAZYME HOMOCYSTEINE POC TEST KIT
- K111664 — DIAZYME CYSTATIN C POC TEST KIT
- K110188 — DIAZYME GLYCATED SERUM PROTEIN ASSAY / CALIBRATOR KIT / CONTROL KIT
- K103557 — DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET
- K102432 — DIAZYME 25-HYDROXY VITAMIN D ASSAY KIT MODEL DZ688A, DIAZYME 25-HYDROXY VITAMIN D ASSAY CALIBRATOR SET MODEL DZ688A-CAL,
- K102638 — DIAZYME HOMOCYSTEINE ASSAY BUFFER BASED CALIBRATORS
- K092911 — SMART HBA1C ASSAY KIT, MODEL DZ168B-POC, SMART HBA1C ASSAY CONTROL KIT, MODEL DZ168B-CON, SMART HBAC1C ANALYZER
- K093680 — DIAZYME CYSTATIN C ASSAY
- K091455 — DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY KIT, MODEL DZ113C-X, DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY CAL
- K082001 — DIAZYME LIQUID STABLE ENZYMATIC LITHIUM ASSAY, MODEL DZ116B
- K082763 — DIAZYME LIQUID STABLE ENZYMATIC SODIUM ASSAY, MODEL DZ114B
- K073488 — DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXX
- K072270 — DIAZYME CYSTATIN C: ASSAY KIT (DZ133A-K), CALIBRATOR (DZ133A-CAL), CONTROLS (DZ133A-CON)
- K072395 — DIAZYME HDL-CHOLESTEROL REAGENT,CALIBRATOR, CONTROLS
- K071971 — DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALIBRATORS, MODEL(S) DZXXXA, DZXXXA-CAL
- K062105 — DIAZYME CREATININE LIQUID REAGENTS ASSAY
- K070734 — MODIFICATION TO: DIRECT ENZYMATIC HBA1C ASSAY KIT, MODEL# DZ168A, DZ168A-CAL, DZ168A-CON
- K060619 — DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122A
- K061296 — DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA AND HOMOCYSTEINE CALIBRATOR
- K053566 — MODIFICATION TO: DIAZYME POTASSIUM ENZYMATIC ASSAY, MODEL DZ113A
- K051714 — TOTAL BILE ACIDS ASSAY, MODEL DZ042A
- K042191 — DIAZYME POTASSIUM ENZYMATIC ASSAY KIT
- K042193 — DIAZYME GLYCATED SERUM PROTEIN ENZYMATIC ASSAY KIT
- K042189 — DIAZYME SODIUM ENZYMATIC ASSAY
- K032012 — HOMOCYSTEINE MICROTITER PLATE ASSAY
Data sourced from openFDA. This site is unofficial and independent of the FDA.