FDA.reportPublic FDA data

HR Series NEFA-HR(2) Solvent A

Primary DI
14987481164618
Brand
HR Series NEFA-HR(2) Solvent A
Company
FUJIFILM WAKO PURE CHEMICAL CORPORATION
Model
995-34791
Catalog number
995-34791
Device description
In-Vitro Diagnostic Use
Published
2021-06-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JLHTitrimetric, Fatty Acids

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JLHTitrimetric, Fatty AcidsClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14987481164618PrimaryGS10
04987481164611Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1498748116461814987481164618
04987481164611049874811646114987481164611

GMDN Terms#

Term, Definition table
TermDefinition
Non-esterified fatty acid IVD, reagentA 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 non-esterified fatty acid in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius10 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
690598875
Device count
4
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04987481164666Autokit Micro Albumin999-06001999-060012021-07-30
04987481164673Autokit Micro Albumin Control Set991-06201991-062012021-06-01
14987481164427uTASWako Chip Cassette993-61601993-616012020-10-23
14987481164465uTASWako AFP-L3 Sample Dilution Buffer997-61501997-615012020-10-23
10856626006080uTASWako Chip Cassette993-61601993-616012016-11-11
10856626006189uTASWako AFP-L3 Sample Dilution Buffer997-61501997-615012016-12-22
04987481164680uTASWako i30991-60301991-603012020-10-23
00856626006229uTASWako i30991-60301991-603012020-06-01
14987481164557HDL-C/LDL-C Calibrator990-28011990-280112020-10-23
14987481164564L-Type HDL-C Reagent 1991-00101991-001012020-10-23
14987481164571L-Type HDL-C Reagent 2997-00201997-002012020-10-23
14987481164588L-Type HDL-C Reagent 1997-72591997-725912020-10-23
14987481164595L-Type HDL-C Reagent 2993-72691993-726912020-10-23
10856626006035HDL-C/LDL-C Calibrator990-28011990-280112016-12-07
10856626006042L-Type HDL-C (Reagent 1) 991-00101991-001012016-11-11
10856626006097L-Type HDL-C Reagent 2993-72691993-726912016-11-23
10856626006141L-Type HDL-C (Reagent 2)997-00201997-002012016-11-11
10856626006196L-Type HDL-C Reagent 1997-72591997-725912016-11-23
14987481164533L-Type LDL-C Reagent 1999-00404999-004042021-06-01
14987481164540L-Type LDL-C Reagent 2999-00504999-005042021-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14987481164601HR Series NEFA-HR(2) Color Reagent AFUJIFILM WAKO PURE CHEMICAL CORPORATIONJLH2021-06-01
14987481164625HR Series NEFA-HR(2) Color Reagent BFUJIFILM WAKO PURE CHEMICAL CORPORATIONJLH2021-06-01
14987481164632HR Series NEFA-HR(2) Solvent BFUJIFILM WAKO PURE CHEMICAL CORPORATIONJLH2021-06-01
04987481164604HR Series NEFA-HR(2) Color Reagent AFUJIFILM WAKO PURE CHEMICAL CORPORATIONJLH2021-06-01
04987481164611HR Series NEFA-HR(2) Solvent AFUJIFILM WAKO PURE CHEMICAL CORPORATIONJLH2021-06-01
04987481164628HR Series NEFA-HR(2) Color Reagent BFUJIFILM WAKO PURE CHEMICAL CORPORATIONJLH2021-06-01
04987481164635HR Series NEFA-HR(2) Solvent BFUJIFILM WAKO PURE CHEMICAL CORPORATIONJLH2021-06-01