FDA.reportPublic FDA data

MERIFLUOR Chlamydia

Primary DI
00840733101205
Brand
MERIFLUOR Chlamydia
Company
MERIDIAN BIOSCIENCE, INC.
Model
500111
Catalog number
500111
Device description
MERIFLUOR Chlamydia is an in vitro direct immunofluorescent detection procedure for the detection of Chlamydia trachomatis and Chlamydia psittaci in McCoy cells
Published
2016-09-23
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
LKIAntisera, Fluorescent, Chlamydia Spp.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LKIAntisera, Fluorescent, Chlamydia Spp.Microbiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K830342000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K830342000CULUTURE SET CHLAMYDIA ISOLATION ANDImmulok, Inc.1983-05-04LKI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840733101205PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840733101205008407331012058407331012050840733101205

GMDN Terms#

Term, Definition table
TermDefinition
Multiple Chlamydia species antigen IVD, kit, direct fluorescent test (DFT)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from one or multiple species of Chlamydia bacteria in a clinical specimen, using a direct fluorescent test (DFT).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling 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
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
00813545025519Chlamydia Trachomatis IgG 120 Test KitSCIMEDX CORPORATIONLKI2016-09-20
00813545025533Chlamydia Trachomatis 10wl 10 pkSCIMEDX CORPORATIONLKI2016-09-20
B110CH41120Chlamydia Antigen Substrate, 12 wells, For IFA Test SystemBion Enterprises, Ltd.LKI2016-09-12
B110CHG41200Chlamydia IgG ControlBion Enterprises, Ltd.LKI2016-09-12
B110CHM41300Chlamydia IgG ControlBion Enterprises, Ltd.LKI2016-09-12
B110CHN41100Chlamydia Negative ControlBion Enterprises, Ltd.LKI2016-09-12