FDA.reportPublic FDA data

Wash Concentrate 3

Primary DI
00817439020086
Brand
Wash Concentrate 3
Company
Medtest Dx, Inc.
Model
10W500
Catalog number
10W500
Device description
This product will be used as a concentrated wash solution on automated analyzers. 6 x 25 ml.
Published
2016-09-27
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JJFAnalyzer, Chemistry, Micro, For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJFAnalyzer, Chemistry, Micro, For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817439020086PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817439020086008174390200868174390200860817439020086

GMDN Terms#

Term, Definition table
TermDefinition
Wash/cleaning solution IVD, automated/semi-automated systemA concentrated wash or cleaning solution intended to be used as a consumable reagent on-board an automated or semi-automated instrument that is used for the processing, staining and/or testing of clinical laboratory specimens.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-445-9853techservice@medtest.com

Regulatory Flags#

DUNS number
070371210
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817439020000Direct Lipid Control Set300030002016-09-27
00817439020017Direct Lipid Control L1300130012016-09-27
00817439020024Direct Lipid Control L2300230022016-09-27
00817439020031Direct Lipid Control L3300330032016-09-27
00817439020062Wash Concentrate 103W50003W5002016-09-27
00817439020079Wash Concentrate 209W50009W5002016-09-27
00817439020093Albumin / BS480ALB480ALB4802016-09-27
00817439020109AlbuminALB505ALB5052016-09-27
00817439020116Albumin / BS200ALB600ALB6002016-09-27
00817439020123Alkaline Phos/ BS480ALP480ALP4802016-09-27
00817439020130ALP ReagentALP505ALP5052016-09-27
00817439020147MedTest DX Alkaline PhosphataseALP600ALP6002016-09-27
00817439020192Amylase / BS480AMY480AMY4802016-09-27
00817439020215Amylase / BS200AMY600AMY6002016-09-27
00817439020222AST / BS480AST480AST4802016-09-27
00817439020239AST / Polychem 180AST505AST5052016-09-27
00817439020246AST / BS200AST600AST6002016-09-27
00817439020314C1 Cleaning SolutionC1S500C1S5002016-09-27
00817439020321Calibrator Level 1 CA1100CA11002016-09-30
00817439020338Calibration Serum Level 2CA1400CA14002016-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810039380307Cholestech LDX™Alere San Diego, Inc.JJF2023-12-20
00810039380512Cholestech LDX™Alere San Diego, Inc.JJF2023-12-20
05055273205893RX daytonaRANDOX LABORATORIES LIMITEDJJF2018-06-07
00854361008003Alere Cholestech LDX®Alere San Diego, Inc.JJF2018-03-30
03661540600180V-Twin®VitalScientific B.V.JJF2016-11-21
00725609000496SPOTCHECKASTORIA-PACIFIC, INC.JJF2016-10-14
00725609000502SPOTCHECKASTORIA-PACIFIC, INC.JJF2016-10-14
00817439020062Wash Concentrate 1Medtest Dx, Inc.JJF2016-09-27
00817439020079Wash Concentrate 2Medtest Dx, Inc.JJF2016-09-27
00817439021373MedTest DX Wash Solution for the BS200Medtest Dx, Inc.JJF2016-09-27
05055273205091RABSRANDOX LABORATORIES LIMITEDJJF2016-09-26
05055273205947WASH conc. 3RANDOX LABORATORIES LIMITEDJJF2016-09-26
05055273205961ISE DIL URNRANDOX LABORATORIES LIMITEDJJF2016-09-26
05055273206043WASH conc. 2RANDOX LABORATORIES LIMITEDJJF2016-09-26
05055273206050WASH conc. 1RANDOX LABORATORIES LIMITEDJJF2016-09-26
05055273206074Cl SOLNRANDOX LABORATORIES LIMITEDJJF2016-09-26
05055273206111NSRANDOX LABORATORIES LIMITEDJJF2016-09-26
05055273206289SABSRANDOX LABORATORIES LIMITEDJJF2016-09-26
05055273206982AWSRANDOX LABORATORIES LIMITEDJJF2016-09-26
05055273210361SOLN WASHRANDOX LABORATORIES LIMITEDJJF2016-09-26
08056771102148LIAISON® XLDIASORIN SPAJJF2016-09-24
00817273020464DiamedixDIAMEDIX CORPORATIONJJF2016-09-21
00817273020471DiamedixDIAMEDIX CORPORATIONJJF2016-09-21
04015630924691cobas 6000 core unitRoche Diagnostics GmbHJJF2016-09-20
04015630924707cobas c 501 ModuleRoche Diagnostics GmbHJJF2016-09-20
04015630925551cobas c 311Roche Diagnostics GmbHJJF2016-09-20
04015630924745COBAS®TaqMan® 48 AnalyzerRoche Molecular Systems, Inc.JJF2014-09-17
04015630925537COBAS® TaqMan®Roche Molecular Systems, Inc.JJF2014-09-15