FDA.reportPublic FDA data

PREMIER Adenoclone Type 40/41

Primary DI
00840733101748
Brand
PREMIER Adenoclone Type 40/41
Company
MERIDIAN BIOSCIENCE, INC.
Model
696006
Catalog number
696006
Device description
Premier Adenoclone-Type 40/41 is an enzyme immunoassay (EIA) for the qualitative detection of enteric adenovirus serotypes 40 and 41 in human fecal specimens.
Published
2020-09-21
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
GODAntigens, Cf (Including Cf Control), Adenovirus 1-33

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GODAntigens, Cf (Including Cf Control), Adenovirus 1-33Microbiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K881894000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K881894000ADENOCLONE(R)-TYPE 40/41 EIA DIAGNOSTIC TEST (48)Cambridge Bioscience Corp.1988-07-08GOD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840733101748PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840733101748008407331017488407331017480840733101748

GMDN Terms#

Term, Definition table
TermDefinition
Adenovirus antigen IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from Adenovirus in a clinical specimen, using an enzyme immunoassay (EIA) method.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
5132713700info@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
08033891327606CHORUS ADENOVIRUS IgGDIESSE DIAGNOSTICA SENESE SPAGOD2024-01-22
04048474034462Adenovirus IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungGOD2023-08-29
00840239034465Adenovirus IgG ELISADRG International IncGOD2023-08-24
00404847434460Adenovirus IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungGOD2021-06-07
00840733101755PREMIER AdenocloneMERIDIAN BIOSCIENCE, INC.GOD2020-10-06
30014613336754InflammaDryQUIDEL CORPORATIONGOD2019-08-02
30014613336686AdenoPlusQUIDEL CORPORATIONGOD2018-11-10
04058863017792Quadrox-iMaquet Cardiopulmonary AGGOD2017-03-13
00722066001905Rapid ResponseBTNX IncGOD2016-10-25