FDA.reportPublic FDA data

Synermed®

Primary DI
05060500091712
Brand
Synermed®
Company
INFRARED LABORATORY SYSTEMS LLC
Model
UV185-1200
Catalog number
UV185-1200
Device description
ALT Reagent 8 X 67 mL + 2 X 67 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
CKANadh Oxidation/Nad Reduction, Alt/Sgpt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CKANadh Oxidation/Nad Reduction, Alt/SgptClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K921016000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K921016000SYNERMED ALT/GPT REAGENT KITSynermed, Inc.1992-05-07CKA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060500091712PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060500091712050605000917125060500091712

GMDN Terms#

Term, Definition table
TermDefinition
Alanine aminotransferase (ALT) 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 alanine aminotransferase (ALT) 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
10673486013580Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSCKA2025-05-28
10673486013726Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSCKA2025-05-28
10673486013894Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSCKA2025-05-28
10673486013962Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSCKA2025-05-28
07613336130513Alanine Aminotransferase acc. to IFCC IIRoche Diagnostics GmbHCKA2024-01-26
00850053916021IDG/SANZAYIDG/SANZAY CorporationCKA2024-01-03
10673486001082ALT (SGPT) LIQUID REAGENT (KINETIC METHOD)TECO DIAGNOSTICSCKA2023-07-17
10673486001099ALT (SGPT) KINETIC METHOD TC MATRIX-240/480TECO DIAGNOSTICSCKA2023-07-17
10673486001105ALT (SGPT) REAGENT SET (UV-KINETIC METHOD)TECO DIAGNOSTICSCKA2023-07-17
10673486001112ALT (SGPT) REAGENT SET (UV-KINETIC METHOD)TECO DIAGNOSTICSCKA2023-07-17
06971674862031BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CKA2023-07-13
06971674862048BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CKA2023-07-13
06971674862055BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CKA2023-07-13
06971674862062BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CKA2023-07-13
06971674862079BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CKA2023-07-13
06971674862086BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CKA2023-07-13
06971674862093BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CKA2023-07-13
06971674862109BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CKA2023-07-13
06971674862116BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CKA2023-07-13
06971674862123BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CKA2023-07-13
06971674862130BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CKA2023-07-13
06971674862147BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CKA2023-07-13
06971674862154BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CKA2023-07-13
06971674862161BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CKA2023-07-13
06971674862178BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CKA2023-07-13
06971674862185BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CKA2023-07-13
06971674862192BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CKA2023-07-13
06971674862208BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CKA2023-07-13
00817302024647CAROLINA LIQUID CHEMISTRIES CORP.® ALKALINE AMINOTRANSFERASE REAGENT AU-240CAROLINA LIQUID CHEMISTRIES CORPORATIONCKA2022-10-18
00817302024111CAROLINA LIQUID CHEMISTRIES CORP.® PHOSPHORUS REAGENT KIT BL218CAROLINA LIQUID CHEMISTRIES CORPORATIONCKA2022-08-19