Diazyme Laboratories, Inc.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
2032900	3004445302	Diazyme Laboratories, Inc.	1	N	2026-01-01	12889 GREGG CT POWAY CA US 92064

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
21855	1597597981	K253069	Lipoprotein (a) Molarity Assay	DFC	2026-06-16
21855	1135820216	K220763	ALPCO Calprotectin Immunoturbidimetric Assay	NXO	2023-04-13
21855	1668510837	K181438	Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain Assay	DFH	2018-06-26
21855	1093128507	K180209	Diazyme 1,5-AG Assay	NOZ	2018-10-04
21855	1854653979	K180074	Diazyme Lipoprotein (a) Assay	DFC	2018-03-22
21855	1632072952	K172992	Diazyme EZ Vitamin D Assay	MRG	2018-01-11
21855	1684664947	K162297	Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set	PTF	2017-04-18
21855	1776831665	K161721	Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set	CDD	2016-09-20
21855	1014621068	K161646	Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set	CGN	2016-11-04
21855	1948916215	K160762	Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set	LCP	2016-11-21
21855	1448031191	K143470	Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set	GIS	2016-01-31
21855	1519260669	K141575	PLAC TEST FOR LP-PLA2 ACTIVITY	NOE	2014-12-15
21855	1018772422	K133410	DIAZYME 25-OH VITAMIN D ASSAY; DIAZYME 25-OH VITAMIN D CONTROL SET	MRG	2014-03-14
21855	1912220118	K131556	DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SET	JIT	2013-06-26
21855	1705252348	K123785	DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SET	DDR	2013-06-07
21855	2059596840	K113793	HOMOCYSTEINE TEST	LPS	2012-06-05
21855	1588146567	K112120	DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET	GHH	2013-01-24
21855	1947152756	K110188	DIAZYME GLYCATED SERUM PROTEIN ASSAY / CALIBRATOR KIT / CONTROL KIT	LCP	2011-05-17
21855	1996744983	K103557	DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET	DCK	2011-04-27
21855	1413416988	K103531	PRESTIGE 24I; BIOLIS 24I; MGC 240	CFR	2011-12-01
21855	1804819594	K093680	DIAZYME CYSTATIN C ASSAY	NDY	2010-04-08
21855	1824303097	K091455	DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY KIT, MODEL DZ113C-X, DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY CAL	MZV	2009-08-14
21855	1784365691	K082763	DIAZYME LIQUID STABLE ENZYMATIC SODIUM ASSAY, MODEL DZ114B	MZU	2008-11-12
21855	1543837468	K082001	DIAZYME LIQUID STABLE ENZYMATIC LITHIUM ASSAY, MODEL DZ116B	JII	2008-12-05
21855	1148332722	K073488	DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXX	MSJ	2008-03-07
21855	1865531660	K072977	DIAZYME APOLIPOPROTEIN A-1 ASSAY	MSJ	2008-07-16
21855	1584672082	K072523	DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS	LBR	2008-01-22
21855	1253507493	K072395	DIAZYME HDL-CHOLESTEROL REAGENT,CALIBRATOR, CONTROLS	LBS	2008-01-03
21855	2064175411	K071971	DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALIBRATORS, MODEL(S) DZXXXA, DZXXXA-CAL	LPS	2007-09-17
21855	1187991251	K070734	MODIFICATION TO: DIRECT ENZYMATIC HBA1C ASSAY KIT, MODEL# DZ168A, DZ168A-CAL, DZ168A-CON	LCP	2007-04-09
21855	1185234302	K062105	DIAZYME CREATININE LIQUID REAGENTS ASSAY	JFY	2007-04-23
21855	1339716249	K060619	DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122A	KHS	2006-07-21
21855	1060398575	K051714	TOTAL BILE ACIDS ASSAY, MODEL DZ042A	KWW	2005-12-07
21855	1788071086	K042448	DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT	JJX	2004-10-29
21855	1034939674
21855	1156872421
21855	1277672950
21855	1614181007
21855	1923568587
21855	2048334056
21855	2058000857

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
LCP	3	2016-11-21
DFC	2	2026-06-16
MRG	2	2018-01-11
LPS	2	2012-06-05
MSJ	2	2008-07-16
NXO	1	2023-04-13
NOZ	1	2018-10-04
DFH	1	2018-06-26
PTF	1	2017-04-18
CGN	1	2016-11-04
CDD	1	2016-09-20
GIS	1	2016-01-31
NOE	1	2014-12-15
JIT	1	2013-06-26
DDR	1	2013-06-07
GHH	1	2013-01-24
CFR	1	2011-12-01
DCK	1	2011-04-27
NDY	1	2010-04-08
MZV	1	2009-08-14
JII	1	2008-12-05
MZU	1	2008-11-12
LBR	1	2008-01-22
LBS	1	2008-01-03
JFY	1	2007-04-23
KHS	1	2006-07-21
KWW	1	2005-12-07
JJX	1	2004-10-29

PMN#

Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer
2021-12-13
Diazyme Laboratories, Inc.
Diazyme Lipoprotein (a) Assay
2018-03-22
Diazyme Laboratories, Inc.

GUDID#

Diazyme - DZ558A-KY1
DIAZYME LABORATORIES, INC.
2020-07-29
Diazyme Procalcitonin Assay - DZ558A-K
DIAZYME LABORATORIES, INC.
2017-09-01
Diazyme - DZ248A-CON
DIAZYME LABORATORIES, INC.
2026-01-21
Diazyme - DZ122A-KY1
DIAZYME LABORATORIES, INC.
2026-01-21
Diazyme - 100148B-CAL
DIAZYME LABORATORIES, INC.
2026-01-21
Diazyme - 100148B-CON
DIAZYME LABORATORIES, INC.
2026-01-21
Diazyme - DZ168C-CAL
DIAZYME LABORATORIES, INC.
2020-07-21
Diazyme - DZ168C-CON
DIAZYME LABORATORIES, INC.
2020-07-21
Diazyme - DZ568A-CA5
DIAZYME LABORATORIES, INC.
2020-07-21
Diazyme - DZ122A-CAL
DIAZYME LABORATORIES, INC.
2016-11-03
Diazyme - DZ122A-CON
DIAZYME LABORATORIES, INC.
2016-11-03
Diazyme - DZ042A-CAL
DIAZYME LABORATORIES, INC.
2016-11-03
Diazyme - DZ042A-CON
DIAZYME LABORATORIES, INC.
2016-11-03
Diazyme - DZ179A-CAL
DIAZYME LABORATORIES, INC.
2016-11-03
Diazyme - DZ179A-CON
DIAZYME LABORATORIES, INC.
2016-11-03
Diazyme - DZ147A-CAL
DIAZYME LABORATORIES, INC.
2016-11-03
Diazyme - DZ147A-CON
DIAZYME LABORATORIES, INC.
2016-11-03
Diazyme - DZ768A-CAL
DIAZYME LABORATORIES, INC.
2016-11-03
Diazyme - DZ768A-CON
DIAZYME LABORATORIES, INC.
2016-11-03
Diazyme - DZ141A-CAL
DIAZYME LABORATORIES, INC.
2016-11-03
Diazyme - DZ152A-CON
DIAZYME LABORATORIES, INC.
2023-11-29
Diazyme - DZ152A-CAL
DIAZYME LABORATORIES, INC.
2023-11-29
Diazyme - DZ152A-KY1
DIAZYME LABORATORIES, INC.
2023-11-29
Diazyme - 10-0148
DIAZYME LABORATORIES, INC.
2020-07-21
Diazyme - DZ168C-KY1
DIAZYME LABORATORIES, INC.
2020-07-21
Diazyme - DZ568A-CON
DIAZYME LABORATORIES, INC.
2016-11-03
Diazyme - DZ116B-CAL
DIAZYME LABORATORIES, INC.
2016-11-03
Diazyme - DZ116B-CON
DIAZYME LABORATORIES, INC.
2016-11-03
Diazyme - DZ179A-K
DIAZYME LABORATORIES, INC.
2016-11-03
Diazyme - DZ147A-K
DIAZYME LABORATORIES, INC.
2016-11-03
Diazyme - DZ768A-K
DIAZYME LABORATORIES, INC.
2016-11-03
Diazyme - DZ568B-BY1
DIAZYME LABORATORIES, INC.
2016-11-03
Diazyme - DZ568B-BY2
DIAZYME LABORATORIES, INC.
2016-11-03
Diazyme - DZ042A-KY1
DIAZYME LABORATORIES, INC.
2016-11-03
Diazyme - DZ042A-K01
DIAZYME LABORATORIES, INC.
2016-11-03
Diazyme - DZ116B-KH1
DIAZYME LABORATORIES, INC.
2016-11-03
Diazyme - 06U9525
DIAZYME LABORATORIES, INC.
2025-10-22
Diazyme - 06U9510
DIAZYME LABORATORIES, INC.
2025-10-22
Diazyme - 06U9626
DIAZYME LABORATORIES, INC.
2025-10-22
Diazyme - DZ136A-K
DIAZYME LABORATORIES, INC.
2016-11-03

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