FDA.reportPublic FDA data

HR Series NEFA-HR(2) Solvent A

Primary DI
04987481164611
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
OTC
false
Sterile
false
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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
690598875
Device count
4
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
14987481164618HR Series NEFA-HR(2) Solvent 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
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