FDA.reportPublic FDA data

Synermed®

Primary DI
05060500091637
Brand
Synermed®
Company
INFRARED LABORATORY SYSTEMS LLC
Model
0853
Catalog number
0853
Device description
Drugs of Abuse Cutoff Calibrator 1 X 15 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
DKBCalibrators, Drug Mixture

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DKBCalibrators, Drug MixtureClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133710000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133710000LZI MULTIPLE ANALYTE SET A;B;C DRUGS OF ABUSE CONTROLSLin-Zhi International, Inc.2014-02-21DKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060500091637PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060500091637050605000916375060500091637

GMDN Terms#

Term, Definition table
TermDefinition
Multiple clinical chemistry analyte IVD, calibratorA material which is used to establish known points of reference for a number of assays intended to be used for the qualitative and/or quantitative detection of one or multiple clinical chemistry analytes, and which together create a full general biochemistry profile.

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
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
00840937114636ImmunalysisIMMUNALYSIS CORPDKB2024-04-19
00840937114643ImmunalysisIMMUNALYSIS CORPDKB2024-04-19
00840937114650ImmunalysisIMMUNALYSIS CORPDKB2024-04-19
00840937114667ImmunalysisIMMUNALYSIS CORPDKB2024-04-19
00613647025291FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.DKB2023-06-20
20613647025295FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.DKB2023-06-20
00840937112083ImmunalysisIMMUNALYSIS CORPDKB2021-02-05
00840937112090ImmunalysisIMMUNALYSIS CORPDKB2021-02-05
00840937112106ImmunalysisIMMUNALYSIS CORPDKB2021-02-05
00840937112113ImmunalysisIMMUNALYSIS CORPDKB2021-02-05
00811727016850Pointe Universal Negative CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00811727017550Pointe Multi-Analyte Set C Urine DAU Low CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00811727017567Pointe Multi-Analyte Set C Urine DAU Cutoff CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00811727017574Pointe Multi-Analyte Set C Urine DAU Intermediate CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00811727017581Pointe Multi-Analyte Set C Urine DAU High CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00811727017611Pointe Multi-Analyte Set D Urine DAU Negative CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00811727017628Pointe Multi-Analyte Set D Urine DAU Low CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00811727017635Pointe Multi-Analyte Set D Urine DAU Cutoff CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00811727017642Pointe Multi-Analyte Set D Urine DAU Intermediate CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00811727017659Pointe Multi-Analyte Set D Urine DAU High CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00811727017680Pointe Multi-Analyte E DAU Negative CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00811727017697Pointe Multi-Analyte E DAU Low CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00811727017703Pointe Multi-Analyte E DAU Cutoff CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00811727017710Pointe Multi-Analyte E DAU Intermediate CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00811727017727Pointe Multi-Analyte E DAU High CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00380740179342AlinityABBOTT LABORATORIESDKB2020-05-11
00380740179359AlinityABBOTT LABORATORIESDKB2020-05-11
00380740179366AlinityABBOTT LABORATORIESDKB2020-05-11
00840937111895ImmunalysisIMMUNALYSIS CORPDKB2020-03-31
00840937111918ImmunalysisIMMUNALYSIS CORPDKB2020-03-31