Autokit CH50

Contact Domains#

Code, Name table
Code	Name
DAE	Complement C9, Antigen, Antiserum, Control

Code, Device, Specialty table
Code	Device	Specialty	Class
DAE	Complement C9, Antigen, Antiserum, Control	Immunology	2

Submission, Supplement table
Submission	Supplement
K954145	000

Submission, Supplement, Device table
Submission	Supplement	Device	Applicant	Decision date	Product code
K954145	000	WAKO AUTOKIT CH50	Wako Chemicals USA, Inc.	1995-12-18	DAE

Identifier, Type, Agency table
Identifier	Type	Agency	Package quantity	Status
00856626006113	Previous	GS1	0
04987481164406	Primary	GS1	0

Source identifier, GTIN-14 normalized, UPC-A table
Source identifier	GTIN-14 normalized	UPC-A	EAN-13
00856626006113	00856626006113	856626006113	0856626006113
04987481164406	04987481164406		4987481164406

Term, Definition table
Term	Definition
Total complement activity (CH50) IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of total complement activity (CH50 ) in a clinical specimen.

Type, Low, High table
Type	Low	High	Condition
Storage Environment Temperature	2 Degrees Celsius	10 Degrees Celsius

Phone, Email table
Phone	Email
781-323-5300	fmsuregulatoryaffairs@fujifilm.com

Primary DI, Brand, Model table
Primary DI	Brand	Model	Catalog	Published
04987481164666	Autokit Micro Albumin	999-06001	999-06001	2021-07-30
04987481164673	Autokit Micro Albumin Control Set	991-06201	991-06201	2021-06-01
14987481164427	uTASWako Chip Cassette	993-61601	993-61601	2020-10-23
14987481164465	uTASWako AFP-L3 Sample Dilution Buffer	997-61501	997-61501	2020-10-23
10856626006080	uTASWako Chip Cassette	993-61601	993-61601	2016-11-11
10856626006189	uTASWako AFP-L3 Sample Dilution Buffer	997-61501	997-61501	2016-12-22
04987481164680	uTASWako i30	991-60301	991-60301	2020-10-23
00856626006229	uTASWako i30	991-60301	991-60301	2020-06-01
14987481164557	HDL-C/LDL-C Calibrator	990-28011	990-28011	2020-10-23
14987481164564	L-Type HDL-C Reagent 1	991-00101	991-00101	2020-10-23
14987481164571	L-Type HDL-C Reagent 2	997-00201	997-00201	2020-10-23
14987481164588	L-Type HDL-C Reagent 1	997-72591	997-72591	2020-10-23
14987481164595	L-Type HDL-C Reagent 2	993-72691	993-72691	2020-10-23
10856626006035	HDL-C/LDL-C Calibrator	990-28011	990-28011	2016-12-07
10856626006042	L-Type HDL-C (Reagent 1)	991-00101	991-00101	2016-11-11
10856626006097	L-Type HDL-C Reagent 2	993-72691	993-72691	2016-11-23
10856626006141	L-Type HDL-C (Reagent 2)	997-00201	997-00201	2016-11-11
10856626006196	L-Type HDL-C Reagent 1	997-72591	997-72591	2016-11-23
14987481164533	L-Type LDL-C Reagent 1	999-00404	999-00404	2021-06-01
14987481164540	L-Type LDL-C Reagent 2	999-00504	999-00504	2021-06-01

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
05051700021098	Optilite® CH50 Reagent	THE BINDING SITE GROUP LIMITED	DAE	2024-11-20
00498748116440	Autokit CH50	FUJIFILM WAKO PURE CHEMICAL CORPORATION	DAE	2020-10-23
04987481164512	CH50 Calibrator	FUJIFILM WAKO PURE CHEMICAL CORPORATION	DAE	2020-10-23
00856626006151	CH50 Calibrator	FUJIFILM WAKO PURE CHEMICAL CORPORATION	DAE	2016-12-07
00856626006113	Autokit CH50	FUJIFILM WAKO PURE CHEMICAL CORPORATION	DAE	2016-11-11
05051700010269	Total Haemolytic Complement	THE BINDING SITE GROUP LIMITED	DAE	2016-09-24
05051700010276	Total Haemolytic Complement	THE BINDING SITE GROUP LIMITED	DAE	2016-09-24
05051700010283	Total Haemolytic Complement	THE BINDING SITE GROUP LIMITED	DAE	2016-09-24
05051700012294	CH50 Eq Enzyme Immunoassay Kit	THE BINDING SITE GROUP LIMITED	DAE	2016-09-24
05051700015592	Human CH50 Reagent pack for use on the SPAPLUS	THE BINDING SITE GROUP LIMITED	DAE	2016-09-24
05051700018210	Optilite CH50 Reagent	THE BINDING SITE GROUP LIMITED	DAE	2016-09-24
30014613335566	MicroVue	QUIDEL CORPORATION	DAE	2016-09-15