FDA.reportPublic FDA data

Alethia™ Group A Streptococcus External Control Kit

Primary DI
00840733102127
Brand
Alethia™ Group A Streptococcus External Control Kit
Company
MERIDIAN BIOSCIENCE, INC.
Model
479910
Catalog number
479910
Device description
The Alethia™ Group A Streptococcus (Group A Strep) External Control Kit contains Positive Reagent for use with the Alethia™ Group A Streptococcus DNA Amplification Assay. The External Positive Control Reagent is used in conjunction with the Alethia™ Sample Preparation Apparatus II/Negative Control III reagent provided with the Group A Strep Kit as part of routine Quality Control Testing. External controls are used as part of a routine quality control program.
Published
2019-01-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OOIReal Time Nucleic Acid Amplification System
OYZGroup A Streptococcus Nucleic Acid Amplification Assay System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OOIReal Time Nucleic Acid Amplification SystemClinical Chemistry2
OYZGroup A Streptococcus Nucleic Acid Amplification Assay SystemMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122019000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122019000STREPTOCOCCUS APP. SEROLOGICAL REAGENTSMeridian Bioscience, Inc.2012-09-13OYZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840733102127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840733102127008407331021278407331021270840733102127

GMDN Terms#

Term, Definition table
TermDefinition
Streptococcus mutans group antigen IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of antigens from Streptococcus mutans group of bacteria in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
513-271-3700info@meridianbioscience.com

Regulatory Flags#

DUNS number
092815364
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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