FDA.reportPublic FDA data

L-Type LDL-C Reagent 1

Primary DI
04987481164536
Brand
L-Type LDL-C Reagent 1
Company
FUJIFILM WAKO PURE CHEMICAL CORPORATION
Model
999-00404
Catalog number
999-00404
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
LBRLdl & Vldl Precipitation, Hdl

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LBRLdl & Vldl Precipitation, HdlClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K982271000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K982271000WAKO DIRECT LDL-CWako Chemicals USA, Inc.1998-09-22MRR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14987481164533PrimaryGS10
04987481164536Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1498748116453314987481164533
04987481164536049874811645364987481164536

GMDN Terms#

Term, Definition table
TermDefinition
Low density lipoprotein (LDL) cholesterol 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 low density lipoprotein (LDL) cholesterol lipid 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
2
DM exempt
false
Premarket exempt
false
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
06935740725705Blood Lipid AnalyzerUrit Medical Electronic Co., Ltd.LBR2026-06-03
06935740725712Blood Lipid AnalyzerUrit Medical Electronic Co., Ltd.LBR2026-06-03
00682607690053Mission Cholesterol Test Device - 3-in-1 Lipid Panel 25TAcon Laboratories, Inc.LBR2026-03-09
00682607690077Mission Cholesterol Optical Check DeviceAcon Laboratories, Inc.LBR2026-03-09
00682607690084Mission Cholesterol Control SolutionAcon Laboratories, Inc.LBR2026-03-09
00682607690091Mission Cholesterol Test Device - 3-in-1 Lipid Panel 5TAcon Laboratories, Inc.LBR2026-03-09
10682607690050Mission Cholesterol Test Device - 3-in-1 Lipid Panel 25TAcon Laboratories, Inc.LBR2026-03-09
00682607690060Mission Cholesterol MeterAcon Laboratories, Inc.LBR2026-03-09
10682607690081Mission Cholesterol Control SolutionAcon Laboratories, Inc.LBR2026-03-09
06935740726986Blood Lipid Test StripUrit Medical Electronic Co., Ltd.LBR2024-07-12
00850053916175IDG/SanzayIDG/SANZAY CorporationLBR2024-01-12
10673486001907Teco Diagnostics Direct HDL Cholesterol Reagent Kit TC-MatrixTECO DIAGNOSTICSLBR2023-11-20
10673486001938Teco Diagnostics HDL Cholesterol Reagent SetTECO DIAGNOSTICSLBR2023-11-20
10673486001884Teco Diagnostics HDL Cholesterol Reagent SetTECO DIAGNOSTICSLBR2023-11-10
10673486001891Teco Diagnostics Direct HDL Cholesterol Reagent SetTECO DIAGNOSTICSLBR2023-11-10
00381934753010Lipid Panel, 15ct., CCPlus HomePOLYMER TECHNOLOGY SYSTEMS, INC.LBR2023-06-20
00381934752013Lipid + eGLU Smart Bundle™ , CC Plus Home (15-pk)POLYMER TECHNOLOGY SYSTEMS, INC.LBR2023-06-01
00887473000337STANDARD™ LipidoCare Lipid Test Strip - Lipid ProfileSD Biosensor, Inc.LBR2023-05-10
00887473000344STANDARD™ LipidoCare Lipid Test Strip - Lipid ProfileSD Biosensor, Inc.LBR2023-05-10
00887473000320STANDARD™ LipidoCare AnalyzerSD Biosensor, Inc.LBR2023-04-07
00381934747019Assy Vial, Lipid Panel Test Strips, 15 ct, CardioChek Plus HomePOLYMER TECHNOLOGY SYSTEMS, INC.LBR2023-03-25
10381934747016Assy Vial, Lipid Panel Test Strips, 15 ct, CardioChek Plus HomePOLYMER TECHNOLOGY SYSTEMS, INC.LBR2023-03-25
00381934749013Assy Vial, Lipid Panel Test Strips, 1 ct, CardioChek Plus HomePOLYMER TECHNOLOGY SYSTEMS, INC.LBR2023-03-25
00887473000290STANDARD™ LipidoCare Lipid Test Strip - Lipid ProfileSD Biosensor, Inc.LBR2023-03-17
00887473000306STANDARD™ LipidoCare Lipid Test Strip - Lipid ProfileSD Biosensor, Inc.LBR2023-03-17
00887473000283STANDARD™ LipidoCare AnalyzerSD Biosensor, Inc.LBR2023-03-17
00381934750019CardioChek Plus Home Self-Test AnalyzerPOLYMER TECHNOLOGY SYSTEMS, INC.LBR2022-04-11
14987481164533L-Type LDL-C Reagent 1FUJIFILM WAKO PURE CHEMICAL CORPORATIONLBR2021-06-01
14987481164540L-Type LDL-C Reagent 2FUJIFILM WAKO PURE CHEMICAL CORPORATIONLBR2021-06-01
04987481164543L-Type LDL-C Reagent 2FUJIFILM WAKO PURE CHEMICAL CORPORATIONLBR2021-06-01