FDA.reportPublic FDA data

HDL-C/LDL-C Calibrator

Primary DI
14987481164557
Brand
HDL-C/LDL-C Calibrator
Company
FUJIFILM WAKO PURE CHEMICAL CORPORATION
Model
990-28011
Catalog number
990-28011
Device description
In-Vitro Diagnostic Use
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#

Product Codes#

Code, Name table
CodeName
JISCalibrator, Primary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JISCalibrator, PrimaryClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K001005000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K001005000WAKO HDL-C/LDL-C CALIBRATORWako Chemicals USA, Inc.2000-06-01JIS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10856626006035PreviousGS10
14987481164557PrimaryGS10
04987481164550Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1085662600603510856626006035
1498748116455714987481164557
04987481164550049874811645504987481164550

GMDN Terms#

Term, Definition table
TermDefinition
High density lipoprotein (HDL) cholesterol IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of high density lipoprotein (HDL) cholesterol lipid 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
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
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
14987481164601HR Series NEFA-HR(2) Color Reagent A999-34691999-346912021-06-01

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