FDA.reportPublic FDA data

Metricide

Primary DI
00615375008577
Brand
Metricide
Company
METREX RESEARCH, LLC
Model
10-602
Device description
OPA TEST STRIPS - 100 COUNT 2 BOTTLES/CS
Published
2023-10-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JOJIndicator, Physical/Chemical Sterilization Process

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOJIndicator, Physical/Chemical Sterilization ProcessGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070419000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070419000OPACIDEN OPA REAGENT STRIPSHach Company2007-08-31JOJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10615375008574PackageGS12In Commercial Distribution
00615375008577PrimaryGS10
00615375007853Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1061537500857410615375008574
00615375008577006153750085776153750085770615375008577
00615375007853006153750078536153750078530615375007853

GMDN Terms#

Term, Definition table
TermDefinition
Ortho-phthalaldehyde (OPA) device disinfectant 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 ortho-phthalaldehyde (OPA) in a device disinfectant solution after preparation to ensure disinfectant properties. It is used to prevent diluting the disinfectant 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
Storage Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
18008411428customercare@kavokerrgroup.com

Regulatory Flags#

DUNS number
145963778
Device count
100
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00615375014158Spark™ TruColor™910181-212026-02-09
00615375014165Spark™ TruColor™910181-222026-02-09
00615375014172Spark™ TruColor™910181-312026-02-09
00615375014189Spark™ TruColor™910181-322026-02-09
00615375014196Spark™ TruColor™910181-412026-02-09
00615375014202Spark™ TruColor™910181-422026-02-09
00615375013731Endeavour™ TruColor™ XL910177-432026-02-06
00615375013748Endeavour™ TruColor™ XL910177-442026-02-06
00615375013755Endeavour™ TruColor™ XL910177-452026-02-06
00615375013762Endeavour™ TruColor™ XL910177-462026-02-06
00615375013779Endeavour™ TruColor™ XL910177-472026-02-06
00615375013786Endeavour™ TruColor™ XL910177-482026-02-06
00615375013793Endeavour™ TruColor™ XL910177-502026-02-06
00615375013809Endeavour™ TruColor™ XL910177-612026-02-06
00615375013816Endeavour™ TruColor™ XL910177-622026-02-06
00615375013823Endeavour™ TruColor™ XL910177-632026-02-06
00615375013830Endeavour™ TruColor™ XL910177-642026-02-06
00615375013847Endeavour™ TruColor™ XL910177-652026-02-06
00615375013854Endeavour™ TruColor™ XL910177-662026-02-06
00615375013861Endeavour™ TruColor™ XL910177-672026-02-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456201053JMUJMU DENTAL, INCJOJ2026-06-05
00840456201060JMUJMU DENTAL, INCJOJ2026-06-05
00840456201077JMUJMU DENTAL, INCJOJ2026-06-05
00840456201275JMUJMU DENTAL, INCJOJ2026-06-05
00840456201282JMUJMU DENTAL, INCJOJ2026-06-05
00840456201299JMUJMU DENTAL, INCJOJ2026-06-05
00840456201305JMUJMU DENTAL, INCJOJ2026-06-05
00840456201312JMUJMU DENTAL, INCJOJ2026-06-05
00840456201831JMUJMU DENTAL, INCJOJ2026-06-05
00840456201848JMUJMU DENTAL, INCJOJ2026-06-05
00840456201855JMUJMU DENTAL, INCJOJ2026-06-05
00840456201862JMUJMU DENTAL, INCJOJ2026-06-05
00840456201879JMUJMU DENTAL, INCJOJ2026-06-05
00840456201886JMUJMU DENTAL, INCJOJ2026-06-05
00840456201893JMUJMU DENTAL, INCJOJ2026-06-05
00840456201909JMUJMU DENTAL, INCJOJ2026-06-05
00840456201916JMUJMU DENTAL, INCJOJ2026-06-05
00840456201923JMUJMU DENTAL, INCJOJ2026-06-05
00840456201930JMUJMU DENTAL, INCJOJ2026-06-05
00840456201947JMUJMU DENTAL, INCJOJ2026-06-05
00840456202951JMUJMU DENTAL, INCJOJ2026-06-05
00840456202968JMUJMU DENTAL, INCJOJ2026-06-05
00840456202975JMUJMU DENTAL, INCJOJ2026-06-05
00840456202982JMUJMU DENTAL, INCJOJ2026-06-05
00840456202999JMUJMU DENTAL, INCJOJ2026-06-05
00840456207208JMUJMU DENTAL, INCJOJ2026-06-05
00840456207215JMUJMU DENTAL, INCJOJ2026-06-05
00840456215180JMUJMU DENTAL, INCJOJ2026-06-05
00840456215197JMUJMU DENTAL, INCJOJ2026-06-05
00840456215203JMUJMU DENTAL, INCJOJ2026-06-05