FDA.reportPublic FDA data

PREMIER CAMPY

Primary DI
00840733101717
Brand
PREMIER CAMPY
Company
MERIDIAN BIOSCIENCE, INC.
Model
618096
Catalog number
618096
Device description
Premier CAMPY enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of specific Campylobacter antigens in stool samples from patients with signs and symptoms of gastroenteritis. Premier CAMPY detects C. jejuni and C. coli in human stool that may be either unpreserved or preserved in Cary-Blair-based transport media. Test results are to be used in conjunction with information obtained from the patient’s clinical evaluation and other diagnostic procedures. Premier CAMPY is not intended for point-of-care use. The device is intended for use in hospital, reference, regional, private or state laboratory settings.
Published
2020-09-01
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
LQPCampylobacter Spp.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LQPCampylobacter Spp.Microbiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K083464000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083464000PREMIER CAMPY, MODEL 618096Meridian Bioscience, Inc.2009-01-30LQP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840733101717PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840733101717008407331017178407331017170840733101717

GMDN Terms#

Term, Definition table
TermDefinition
Campylobacter jejuni antibody IVD, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to Campylobacter jejuni bacteria 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
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
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00840733101557statID Pro COVID-19/Flu External Controls7830102026-04-10
00840733101564statID Pro COVID-19/Flu A&B7830252026-04-10
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
00840733102493Para-Pak Ultra EcoFix9813129813122020-12-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
30014613338772SofiaQUIDEL CARDIOVASCULAR INC.LQP2025-11-18
50014613338776SofiaQUIDEL CARDIOVASCULAR INC.LQP2025-11-18
05032384519583ProSpecT Campylobacter Microplate Assay 96 TestsOXOID LIMITEDLQP2024-06-20
00840733102387Curian CampyMERIDIAN BIOSCIENCE, INC.LQP2023-03-23
00857031002486CAMPYLOBACTER CHEKTECHLAB, INC.LQP2019-08-06
00857031002578QuickVue TLI Campylobacter TestTECHLAB, INC.LQP2019-05-30
00857031002462CAMPYLOBACTER CHEKTECHLAB, INC.LQP2019-05-29
00857031002479CAMPYLOBACTER QUIK CHEKTECHLAB, INC.LQP2019-05-29
00857031002455CAMPYLOBACTER QUIK CHEKTECHLAB, INC.LQP2019-04-12
00840733101373ImmunoCard STAT! CAMPYMERIDIAN BIOSCIENCE, INC.LQP2018-08-06
00813545026288CAMPY (jcl) Latex 50 Test Kit SCIMEDX CORPORATIONLQP2016-09-21