ImmunoCard STAT! Rotavirus

Primary DI
00840733101809
Brand
ImmunoCard STAT! Rotavirus
Company
MERIDIAN BIOSCIENCE, INC.
Model
750030
Catalog number
750030
Device description
The ImmunoCard STAT! Rotavirus Immunoassay is a rapid in vitro qualitative procedure for the detection of rotavirus antigen in human stool. The test can be used to aid in the diagnosis of rotavirus associated gastroenteritis.
Published
2020-08-11
Public version status
Update
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
LIQEnzyme Linked Immunoabsorbent Assay, Rotavirus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LIQEnzyme Linked Immunoabsorbent Assay, RotavirusMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K971585000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K971585000IMMUNOCARD STAT! ROTAVIRUSMeridian Diagnostics, Inc.1997-08-20LIQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840733101809PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840733101809008407331018098407331018090840733101809

GMDN Terms#

Term, Definition table
TermDefinition
Rotavirus antigen IVD, kit, immunochromatographic test (ICT), rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from Rotavirus in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses.

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
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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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840733101700PREMIER RotacloneMERIDIAN BIOSCIENCE, INC.LIQ2020-09-01
00722066001899Rapid ResponseBTNX IncLIQ2016-10-25