FDA.reportPublic FDA data

Synermed®

Primary DI
05060500091521
Brand
Synermed®
Company
INFRARED LABORATORY SYSTEMS LLC
Model
IR462-L
Catalog number
IR462-L
Device description
Uric Acid Enzyme Reagent 6 X 500 mL
Published
2016-09-20
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
KNKAcid, Uric, Uricase (Colorimetric)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNKAcid, Uric, Uricase (Colorimetric)Clinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K923414000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K923414000SYNERMED 600 NM URIC ACID REAGENT KITSynermed, Inc.1992-09-22KNK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060500091521PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060500091521050605000915215060500091521

GMDN Terms#

Term, Definition table
TermDefinition
Uric 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 uric acid 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
00630414654133Atellica CH UASiemens Healthcare Diagnostics Inc.KNK2026-04-08
08806141304043ONE+Step Uric AcidDFI CO.,LTDKNK2025-09-04
08806141304036ONE+Step Uric AcidDFI CO.,LTDKNK2025-09-03
08806141304029ONE+Step Uric AcidDFI CO.,LTDKNK2025-08-22
00850053916168IDG/SanzayIDG/SANZAY CorporationKNK2024-01-12
10673486002263Teco Diagnostics Uric Acid Liquid Reagent SetTECO DIAGNOSTICSKNK2023-11-30
10673486002300Teco Diagnostics Uric Acid Reagent SetTECO DIAGNOSTICSKNK2023-11-15
10673486002317Teco Diagnostics Uric Acid Reagent SetTECO DIAGNOSTICSKNK2023-11-15
10673486002324Teco Diagnostics Uric Acid Liquid Reagent SetTECO DIAGNOSTICSKNK2023-11-15
10673486002331Teco Diagnostics Uric Acid Liquid Reagent Kit TC-Matrix-240TECO DIAGNOSTICSKNK2023-11-15
10673486002348Teco Diagnostics Uric Acid Liquid Reagent SetTECO DIAGNOSTICSKNK2023-11-15
10673486002355Teco Diagnostics Uric Acid Liquid Reagent Kit TC-Matrix-480TECO DIAGNOSTICSKNK2023-11-15
06971674863908BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KNK2023-07-14
06971674863915BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KNK2023-07-14
06971674863946BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KNK2023-07-14
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06971674863977BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KNK2023-07-14
06971674864011BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KNK2023-07-14
06971674864028BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KNK2023-07-14
06971674864042BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KNK2023-07-14
06971674863922BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KNK2023-07-13
06971674863939BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KNK2023-07-13
06971674863953BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KNK2023-07-13
06971674863984BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KNK2023-07-13
06971674863991BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KNK2023-07-13
06971674864004BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KNK2023-07-13
06971674864035BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KNK2023-07-13
06971674864059BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KNK2023-07-13
06971674864066BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KNK2023-07-13
06971674864073BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KNK2023-07-13