FDA.reportPublic FDA data

MetriCide

Primary DI
10615375013516
Brand
MetriCide
Company
METREX RESEARCH, LLC
Model
10-602A
Device description
MetriCide OPA Plus Solution Test Strips - 60 COUNT 2 BOTTLES/CS
Published
2025-03-21
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
K241344000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241344000MetriCide™ OPA Plus Solution Test StripSteris2024-06-11JOJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00615375013526PackageGS12In Commercial Distribution
10615375013516PrimaryGS10
00615375013519Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00615375013526006153750135266153750135260615375013526
1061537501351610615375013516
00615375013519006153750135196153750135190615375013519

GMDN Terms#

Term, Definition table
TermDefinition
Medical device disinfection solution 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 the active ingredient in a device disinfectant and/or sterilant solution after preparation, to ensure disinfectant/sterilant properties. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Storage environment temperature between 59 - 86 deg F

Contacts#

Phone, Email table
PhoneEmail
1-800-841-1428customercare@kavokerrgroup.com

Regulatory Flags#

DUNS number
145963778
Device count
60
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

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Primary DI, Brand, Company table
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00840456202999JMUJMU DENTAL, INCJOJ2026-06-05
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00840456207215JMUJMU DENTAL, INCJOJ2026-06-05