FDA.reportPublic FDA data

Synermed®

Primary DI
05060500091996
Brand
Synermed®
Company
INFRARED LABORATORY SYSTEMS LLC
Model
IR059-1200
Catalog number
IR059-1200
Device description
LDL-Cholesterol Reagent 2 X 66 mL + 1 X 44 mL
Published
2017-02-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K072523000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072523000DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLSGeneral Atomics2008-01-22LBR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060500091996PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060500091996050605000919965060500091996

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 Temperature0 Degrees Celsius4 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
317 896-1565info@irlabsystems.com

Regulatory Flags#

DUNS number
014210494
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060500090029Synermed®IR010-RIR010-R2016-09-20
05060500090036Synermed®IR010-XIR010-X2016-09-20
05060500090043Synermed®IR010-WKIR010-WK2016-09-20
05060500090050Synermed®IR010-911IR010-9112016-09-20
05060500090067Synermed®IR010-LIR010-L2016-09-20
05060500091682Synermed®IR010-1200IR010-12002017-02-28
05060500090739Synermed®VI560-RVI560-R2016-09-20
05060500090746Synermed®VI5600-XVI5600-X2016-09-20
05060500090753Synermed®VI560-WKVI560-WK2016-09-20
05060500090760Synermed®VI560-911VI560-9112016-09-20
05060500090777Synermed®VI561-LVI561-L2016-09-20
05060500090784Synermed®VI562-LVI562-L2016-09-20
05060500091873Synermed®VI560-1200VI560-12002017-02-28
05060500090005Synermed®IR-500IR-5002016-09-20
05060500090012Synermed®IR-1200IR-12002016-12-12
05060500091538Synermed®IR954IR9542016-09-20
05060500091545Synermed®IR961-XIR961-X2016-09-20
05060500091552Synermed®IR962-XIR962-X2016-09-20
05060500091590Synermed®ISE530-KISE530-K2016-09-20
05060500091613Synermed®0010012016-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
04987481164536L-Type LDL-C Reagent 1FUJIFILM WAKO PURE CHEMICAL CORPORATIONLBR2021-06-01
04987481164543L-Type LDL-C Reagent 2FUJIFILM WAKO PURE CHEMICAL CORPORATIONLBR2021-06-01
00381934721019CardioChek Plus Home Lipid + eGLU Smart Bundle Self-Test 2ctPOLYMER TECHNOLOGY SYSTEMS, INC.LBR2021-02-08