FDA.reportPublic FDA data

ImmunoCard STAT E. coli O157 Plus

Primary DI
00840733101816
Brand
ImmunoCard STAT E. coli O157 Plus
Company
MERIDIAN BIOSCIENCE, INC.
Model
750530
Catalog number
750530
Device description
The ImmunoCard STAT E. coli O157 Plus is a rapid test for the detection of antigens from Shiga toxin-production E. coli O157 as an aid in the diagnosis of E. coli O157:H7 infection. The test can be used to directly test stool specimens, stool in modified Cary-Blair medium or confirmatory stool cultures grown in MacConkey broth of sorbitol MacConkey (SMAC) plates.In the US, ImmunoCard STAT E. coli O157 Plus is not intended for point-of-care use. This device is intended for moderately complex laboratories. In Canada, this device is not intended for point-of-care use.
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
GMZAntigens, All Types, Escherichia Coli

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GMZAntigens, All Types, Escherichia ColiMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K023599000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K023599000IMMUNOCARD STAT! E. COLI O157 PLUSMeridian Bioscience, Inc.2003-01-03GMZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840733101816PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840733101816008407331018168407331018160840733101816

GMDN Terms#

Term, Definition table
TermDefinition
Escherichia coli 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 Escherichia coli (E. coli) bacteria in a clinical specimen and/or culture isolate, 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
00840733103308Curian Shiga Toxin MERIDIAN BIOSCIENCE, INC.GMZ2023-05-26
05713106818299E. coli reference strain O187Ssi Diagnostica A/SGMZ2021-08-01
05713106818329E. coli reference strain O1Ssi Diagnostica A/SGMZ2021-08-01
05713106818336E. coli reference strain O2Ssi Diagnostica A/SGMZ2021-08-01
05713106818343E. coli reference strain O3Ssi Diagnostica A/SGMZ2021-08-01
05713106818350E. coli reference strain O4Ssi Diagnostica A/SGMZ2021-08-01
05713106818381E. coli reference strain O5Ssi Diagnostica A/SGMZ2021-08-01
05713106818398E. coli reference strain O6Ssi Diagnostica A/SGMZ2021-08-01
05713106818404E. coli reference strain O7Ssi Diagnostica A/SGMZ2021-08-01
05713106818411E. coli reference strain O8Ssi Diagnostica A/SGMZ2021-08-01
05713106818428E. coli reference strain O9Ssi Diagnostica A/SGMZ2021-08-01
05713106818435E. coli reference strain O10Ssi Diagnostica A/SGMZ2021-08-01
05713106818442E. coli reference strain O11Ssi Diagnostica A/SGMZ2021-08-01
05713106818459E. coli reference strain O12Ssi Diagnostica A/SGMZ2021-08-01
05713106818466E. coli reference strain O13Ssi Diagnostica A/SGMZ2021-08-01
05713106818473E. coli reference strain O14Ssi Diagnostica A/SGMZ2021-08-01
05713106818480E. coli reference strain O15Ssi Diagnostica A/SGMZ2021-08-01
05713106818497E. coli reference strain O16Ssi Diagnostica A/SGMZ2021-08-01
05713106818503E. coli reference strain O17Ssi Diagnostica A/SGMZ2021-08-01
05713106818510E. coli reference strain O18abSsi Diagnostica A/SGMZ2021-08-01
05713106818541E. coli reference strain O18acSsi Diagnostica A/SGMZ2021-08-01
05713106818558E. coli reference strain O19abSsi Diagnostica A/SGMZ2021-08-01
05713106818565E. coli reference strain O20Ssi Diagnostica A/SGMZ2021-08-01
05713106818572E. coli reference strain O21Ssi Diagnostica A/SGMZ2021-08-01
05713106818589E. coli reference strain O22Ssi Diagnostica A/SGMZ2021-08-01
05713106818596E. coli reference strain O23Ssi Diagnostica A/SGMZ2021-08-01
05713106818602E. coli reference strain O24Ssi Diagnostica A/SGMZ2021-08-01
05713106818619E. coli reference strain O25Ssi Diagnostica A/SGMZ2021-08-01
05713106818626E. coli reference strain O26Ssi Diagnostica A/SGMZ2021-08-01
05713106818640E. coli reference strain O27Ssi Diagnostica A/SGMZ2021-08-01