FDA.reportPublic FDA data

GlutarTest 1

Primary DI
G212GT23101
Brand
GlutarTest 1
Company
Ibt Scientific LLC
Model
GT23101
Device description
1 bottle of 100 test strips to test glutaraldehyde
Published
2022-01-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
LIFDialyzer Reprocessing System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LIFDialyzer Reprocessing SystemGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K002011000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K002011000GLUTARTEST 1 REAGENT STRIPIntegrated Biomedical Technology, Inc.2001-01-22MSY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G212GT23101PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Glutaraldehyde 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 glutaraldehyde 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
016808871
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G212WS20301WaterSoftWS203012025-12-12
G212WS21350WaterSoft 0-30WS213502025-12-12
G212HP20401Peracid TestHP204012022-01-06
G212CM20201WaterCheck2CM202012022-01-06
G212CP20101WaterCheckCPCP201012022-01-06
G212PX20501RenalCheck PXPX205012022-01-06
G212RC22101WaterCheckRCRC221012022-01-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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.LIF2017-05-23
00382830034456NATUS NEUROLOGY NATUS NEUROLOGY INCORPORATEDLIF2017-03-17
00858293006120Micro-XREPROCESSING PRODUCTS CORPORATIONLIF2017-03-07
00851575007044SteriChek® Peroxide Reagent StripsHACH COMPANYLIF2016-09-23
00851575007075SteriChek® Residual Peroxide Reagent StripsHACH COMPANYLIF2016-09-23
00851575007150SteriChek® Peracetic Acid Reagent StripsHACH COMPANYLIF2016-09-23
M17451051Serim® GUARDIAN™ Residual Peroxide Test Strips SERIM RESEARCH CORPORATIONLIF2016-09-08
M17451052Serim® GUARDIAN™ Residual Peroxide Test Strips SERIM RESEARCH CORPORATIONLIF2016-09-08
M17451121Serim® GUARDIAN™ Residual Formaldehyde Test Strips SERIM RESEARCH CORPORATIONLIF2016-09-08
00898021000037Maky 21.1Angelini Pharma Inc.LIF2016-08-29