uTASWako Chip Cassette

Primary DI: 14987481164427
Brand: uTASWako Chip Cassette
Company: FUJIFILM WAKO PURE CHEMICAL CORPORATION
Model: 993-61601
Catalog number: 993-61601
Device description: The uTASWako chip cassette is designed to be used for the assays on the uTASWako i30.
Published: 2020-10-23
Public version status: Update
Distribution status: In Commercial Distribution
MRI safety: Labeling does not contain MRI Safety Information
Rx: true
Single use: true

Contact Domains#

Code, Name table
Code	Name
NSF	Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment

Code, Device, Specialty table
Code	Device	Specialty	Class
NSF	Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment	Immunology	2

Submission, Supplement table
Submission	Supplement
K100464	000

Submission, Supplement, Device table
Submission	Supplement	Device	Applicant	Decision date	Product code
K100464	000	UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION	Wako Chemicals USA, Inc.	2011-02-23	NSF

Identifier, Type, Agency table
Identifier	Type	Agency
10856626006080	Previous	GS1
14987481164427	Primary	GS1
04987481164420	Unit of Use	GS1

Term, Definition table
Term	Definition
Alpha-fetoprotein-L3 fraction (AFP-L3) IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of alpha-fetoprotein-L3 fraction (AFP-L3) in a clinical specimen, using a fluorescent immunoassay method. It is typically used to aid in the diagnosis of hepatocellular carcinoma (HCC).

Type, Low, High table
Type	Low	High	Condition
Special Storage Condition, Specify	0	0	Store at room temperature

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
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
14987481164601	HR Series NEFA-HR(2) Color Reagent A	999-34691	999-34691	2021-06-01

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
14987481164465	uTASWako AFP-L3 Sample Dilution Buffer	FUJIFILM WAKO PURE CHEMICAL CORPORATION	NSF	2020-10-23
14987481164502	uTASWako Wash Solution	FUJIFILM WAKO PURE CHEMICAL CORPORATION	NSF	2020-10-23
04987481164390	uTASWako AFP-L3	FUJIFILM WAKO PURE CHEMICAL CORPORATION	NSF	2020-10-23
04987481164420	uTASWako Chip Cassette	FUJIFILM WAKO PURE CHEMICAL CORPORATION	NSF	2020-10-23
04987481164468	uTASWako AFP-L3 Sample Dilution Buffer	FUJIFILM WAKO PURE CHEMICAL CORPORATION	NSF	2020-10-23
04987481164505	uTASWako Wash Solution	FUJIFILM WAKO PURE CHEMICAL CORPORATION	NSF	2020-10-23
10856626006189	uTASWako AFP-L3 Sample Dilution Buffer	FUJIFILM WAKO PURE CHEMICAL CORPORATION	NSF	2016-12-22
10856626006059	uTASWako Wash Solution	FUJIFILM WAKO PURE CHEMICAL CORPORATION	NSF	2016-12-07
00856626006205	uTASWako AFP-L3	FUJIFILM WAKO PURE CHEMICAL CORPORATION	NSF	2016-12-07
10856626006080	uTASWako Chip Cassette	FUJIFILM WAKO PURE CHEMICAL CORPORATION	NSF	2016-11-11