FDA.reportPublic FDA data

Alethia™ CMV External Control Kit

Primary DI
00840733102097
Brand
Alethia™ CMV External Control Kit
Company
MERIDIAN BIOSCIENCE, INC.
Model
479880
Catalog number
479880
Device description
The Alethia™ CMV External Control Kit contains Positive and Negative Control Reagents for use with the Alethia CMV DNA Amplification Assay. External controls are used as part of a routine quality control program to aid the user in detection of unexpected conditions that may lead to test errors.
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
QDZQualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QDZQualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus InfectionMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840733102097PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840733102097008407331020978407331020970840733102097

GMDN Terms#

Term, Definition table
TermDefinition
Cytomegalovirus (CMV) nucleic acid IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from cytomegalovirus (CMV) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840733101595StatID PRO COVID/Flu A&B Swabs7831107831102026-05-14
00840733101557statID Pro COVID-19/Flu External Controls7830102026-04-10
00840733101564statID Pro COVID-19/Flu A&B7830252026-04-10
00840733101717PREMIER CAMPY6180966180962020-09-01
00840733101397Fungal Immunodiffusion Plates - 4 Series1010091010092019-11-21
00840733101403Fungal Immunodiffusion Plates - 1 Series1010121010122019-11-21
00840733101014ANA Screen ELISA Test Kit488426148842612016-09-23
00840733102585Hemo-De8013008013002020-12-09
00840733102660Modified Hemo-De8016008016002020-09-21
00840733102318Revogene6102106102102020-07-15
00840733102547EcoStain8014008014002020-12-09
00840733102394SpinCon9722009722002020-10-26
00840733103285Revogene Check6102206102202022-06-27
00840733103339Para-Pak C&S9006-019006122021-06-18
00840733102011Para-Pak C&S9006129006122020-12-09
00840733102714Para-Pak C&S9006129006122020-12-09
00840733102455Para-Pak Ultra SAF9802129802122020-12-09
00840733102851Para-Pak Ultra SAF9802129802122020-12-09
00840733101304MERIFLUOR GullSORB XX715XX7152016-09-23
00840733102899Para-Pak SAF in Tubs9901609901602020-12-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20816101025835Simplexa Congenital CMV DirectDIASORIN MOLECULAR LLCQDZ2023-06-16
20816101025842Simplexa Congenital CMV Positive Control PackDIASORIN MOLECULAR LLCQDZ2023-06-16
00840733102080Alethia™ CMVMERIDIAN BIOSCIENCE, INC.QDZ2019-01-09