FDA.reportPublic FDA data

SteriChek® Peracetic Acid Reagent Strips

Primary DI
00851575007150
Brand
SteriChek® Peracetic Acid Reagent Strips
Company
HACH COMPANY
Model
811906
Catalog number
811906
Device description
Reagent test strip for measuring the concentration of peracetic acid in dialyzer reprocessing.
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LIFDialyzer Reprocessing System
MSYStrip, Test, Reagent, Residuals For Dialysate, Disinfectant

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LIFDialyzer Reprocessing SystemGastroenterology, Urology2
MSYStrip, Test, Reagent, Residuals For Dialysate, DisinfectantGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K980164000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K980164000STERICHEK PERACETIC ACID REAGENT STRIPSEnvironmental Test Systems, Inc.1998-04-16MSY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851575007150PrimaryGS10
00851575007082Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851575007150008515750071508515750071500851575007150
00851575007082008515750070828515750070820851575007082

GMDN Terms#

Term, Definition table
TermDefinition
Peracetic acid device disinfectant/sterilant test stripA sliver of absorbent material impregnated with chemical indicators and dyes intended to be used to rapidly indicate, through colour change, the concentration of peracetic acid in a device disinfectant and/or sterilant solution after preparation to ensure disinfectant/sterilant properties. It is used to prevent diluting the disinfectant/sterilant to a concentration that is lower than the manufacturer's recommended minimum effective concentration (MEC). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length3.25Inch
Width0.2Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature60 Degrees Fahrenheit90 Degrees Fahrenheit
Special Storage Condition, Specify00Must be kept in the original bottle with the lid tightly closed. Do not remove dessicant pack.
Storage Environment Temperature60 Degrees Fahrenheit90 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-970-278-4951etscustomerservice@hach.com

Regulatory Flags#

DUNS number
091381780
Device count
600
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851575007389Stericide Peroxide Reagent Strips811905B811905B2020-04-14
00851575007044SteriChek® Peroxide Reagent Strips8119058119052016-09-23
00851575007075SteriChek® Residual Peroxide Reagent Strips8119058219712016-09-23
00851575007112SteriChek® Blood Leak Reagent Strips8120148121452016-10-28
00851575007020SteriChek® Residual Chlorine Reagent Strips8119008119002016-11-23
00851575007051SteriChek® Total Chlorine Test Kit8119028119022016-11-23
00851575007068Sterichek® Total Chlorine Test Kit Refill8119028119032016-11-23
00851575007105SteriChek® Blood Leak Reagent Strips8120148120142016-10-28
00851575007143Sterichek® BiCarb pH Reagent Strips8119168119162016-10-28
00851575007129SteriChek® Blood Leak Reagent Strips8120148121452016-10-28
00851575007273HACH974660097466002017-05-12
00851575007181HACH973010097301002017-05-12
00851575007198HACH963860096386002017-05-12
00851575007242HACH971730097173002017-05-12
00851575007297HACH963890096389002017-05-12
00851575007310HACH974730097473002017-05-12
00851575007334HACH974740097474002017-05-12
00851575007358HACH974750097475002017-05-12
00851575007365HACH975660097566002017-05-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860006352165Chlorine Sentinel IINelson Environmental Technologies IncMSY2025-04-16
00860006352103Basic Chlorine SentinelNelson Environmental Technologies IncMSY2022-07-06
G212GT23101GlutarTest 1Ibt Scientific LLCLIF2022-01-06
00851575007389Stericide Peroxide Reagent StripsHACH COMPANYLIF2020-04-14
00677964007972Renalin Residual Test StripsMEDIVATORS INC.LIF2018-07-09
10677964007979Renalin Residual Test StripsMEDIVATORS INC.LIF2018-07-09
10677964009119Perassay 500 Peracetic Acid Test StripsMEDIVATORS INC.LIF2018-07-09
00898021000235PeraSidualAngelini Pharma Inc.LIF2017-05-23
00898021000242PeraChekAngelini Pharma Inc.MSY2017-05-23
00898021000242PeraChekAngelini Pharma Inc.LIF2017-05-23
00382830034456NATUS NEUROLOGY NATUS NEUROLOGY INCORPORATEDLIF2017-03-17
00858293006052RPCREPROCESSING PRODUCTS CORPORATIONMSY2017-03-07
00858293006328EZ-ChekREPROCESSING PRODUCTS CORPORATIONMSY2017-03-07
10858293006059RPCREPROCESSING PRODUCTS CORPORATIONMSY2017-03-07
00858293006083RPCREPROCESSING PRODUCTS CORPORATIONMSY2017-03-07
00858293006113Micro-XREPROCESSING PRODUCTS CORPORATIONMSY2017-03-07
00858293006120Micro-XREPROCESSING PRODUCTS CORPORATIONLIF2017-03-07
10858293006325EZ-ChekREPROCESSING PRODUCTS CORPORATIONMSY2017-03-07
00858293006380EZ-ChekREPROCESSING PRODUCTS CORPORATIONMSY2017-03-07
00858293006038RPCREPROCESSING PRODUCTS CORPORATIONMSY2017-01-19
00858293006045RPCREPROCESSING PRODUCTS CORPORATIONMSY2017-01-19
10858293006035RPCREPROCESSING PRODUCTS CORPORATIONMSY2017-01-19
30858293006046RPCREPROCESSING PRODUCTS CORPORATIONMSY2017-01-19
00858293006069RPCREPROCESSING PRODUCTS CORPORATIONMSY2017-01-19
00858293006076RPCREPROCESSING PRODUCTS CORPORATIONMSY2017-01-19
00858293006090EZ-ChekREPROCESSING PRODUCTS CORPORATIONMSY2017-01-19
00858293006106EZ-ChekREPROCESSING PRODUCTS CORPORATIONMSY2017-01-19
00851575007020SteriChek® Residual Chlorine Reagent StripsHACH COMPANYMSY2016-11-23
00851575007051SteriChek® Total Chlorine Test KitHACH COMPANYMSY2016-11-23
00851575007068Sterichek® Total Chlorine Test Kit RefillHACH COMPANYMSY2016-11-23