FDA.reportPublic FDA data

Synermed®

Primary DI
05060500090005
Brand
Synermed®
Company
INFRARED LABORATORY SYSTEMS LLC
Model
IR-500
Catalog number
IR-500
Device description
Automated Clinical Chemistry Analyzer IVD
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JIQTurbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JIQTurbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)Clinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K935662000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K935662000SYNERMED IR 500 CHEMISTRY ANALYZERSynermed, Inc.1994-04-26JIQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060500090005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060500090005050605000900055060500090005

GMDN Terms#

Term, Definition table
TermDefinition
Multiple clinical chemistry analyser IVD, laboratory, automatedAn electrically-powered laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of multiple clinical chemistry analytes in a clinical specimen. Analytes detected may include electrolytes, specific proteins, lipids and kidney, liver and/or cardiac function test analytes. The analyser typically requires analyte specific test kits or reagents, using one or more technologies which may include microfluidics, electrometry, spectrophotometry, fluorimetry, radiometry and/or chemiluminescence. The device operates with minimal technician involvement and complete automation of all procedural steps.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity20 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature20 Degrees Celsius25 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
Serial number
true
Manufacturing 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
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
05060500091620Synermed®085208522016-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380740190316ARCHITECTABBOTT IRELANDJIQ2022-05-25
00380740190781AlinityABBOTT IRELANDJIQ2022-02-28
04987481164666Autokit Micro AlbuminFUJIFILM WAKO PURE CHEMICAL CORPORATIONJIQ2021-07-30
00192024031143Ricca Chemical Company®Ricca Chemical Company, LLCJIQ2021-02-04
00192024031150Ricca Chemical Company®Ricca Chemical Company, LLCJIQ2021-02-04
00192024068545Ricca Chemical Company®Ricca Chemical Company, LLCJIQ2021-02-04
00192024068552Ricca Chemical Company®Ricca Chemical Company, LLCJIQ2021-02-04
03610230008621Yumizen C1200 Urinary ProteinsHORIBA ABX SASJIQ2020-09-09
00380740135201AlinityAbbott GmbHJIQ2018-08-31
00380740119416ARCHITECTAbbott GmbHJIQ2017-01-31
00380740119393ARCHITECTAbbott GmbHJIQ2016-12-31
00380740119409ARCHITECTAbbott GmbHJIQ2016-12-31
00380740003630ARCHITECTABBOTT LABORATORIESJIQ2016-09-09
00380740003647ARCHITECTABBOTT LABORATORIESJIQ2016-09-09
00380740003654ARCHITECTABBOTT LABORATORIESJIQ2016-09-09
15099590180164IMMAGE Beckman Coulter, Inc.JIQ2016-08-24
03610230005057ABX PENTRA URINARY PROTEINS CPHORIBA ABX SASJIQ2016-08-23