FDA.reportPublic FDA data

MERIFLUOR Cryptosporidium/Giardia

Primary DI
00840733101113
Brand
MERIFLUOR Cryptosporidium/Giardia
Company
MERIDIAN BIOSCIENCE, INC.
Model
250050
Catalog number
250050
Device description
MERIFLUOR Cryptosporidium/Giardia (MERIFLUOR C/G) is an in vitro direct immunofluorescent detection procedure for the simultaneous detection of Cryptosporidium oocysts and Giardia cysts in fecal material.
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
MHIGiardia Spp.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MHIGiardia Spp.Microbiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840733101113PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840733101113008407331011138407331011130840733101113

GMDN Terms#

Term, Definition table
TermDefinition
Multiple faecal parasite 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 one or multiple faecal parasite antigens (e.g., Giardia, Entamoeba and Cryptosporidium species) 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
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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
07290115934298T-Handle with Pendulum AdaptorPREMIA SPINE LTDMHI2024-09-03
0404847405955721-Hydroxylase Autoantibody ELISA DRG Instruments Gesellschaft mit beschränkter HaftungMHI2023-09-01
04048474034776Giardia lamblia Antigen (stool) ELISA DRG Instruments Gesellschaft mit beschränkter HaftungMHI2023-08-29
00840239060594Giardia/Cryptosporidium Ag (stool) ELISA DRG International IncMHI2023-08-26
00840239034779Giardia lamblia Antigen (stool) ELISA DRG International IncMHI2023-08-24
00848838026683ProSpecTREMEL, INC.MHI2022-12-23
00083059070699Giardia ELISA [Enzyme-Linked ImmunoSorbent Assay]BIOMERICA, INC.MHI2020-07-01
00083059150155EZ-GIARDIA One-Step Giardia TestBIOMERICA, INC.MHI2020-07-01
00857031002547TRI-COMBO PARASITE SCREENTECHLAB, INC.MHI2019-05-31
00857031002400TRI-COMBO PARASITE SCREENTECHLAB, INC.MHI2017-10-05
00742860100017ImmunoStat G/C 30 Test KitSEKISUI DIAGNOSTICS, LLCMHI2017-01-10
08305900070699Giardia ELISA [Enzyme-Linked ImmunoSorbent Assay]BIOMERICA, INC.MHI2016-12-08
08305901501154EZ-GIARDIA One-Step Giardia TestBIOMERICA, INC.MHI2016-12-08
00613647000304Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.MHI2016-09-24
00848838026850NAREMEL, INC.MHI2016-09-24
00848838026867NAREMEL, INC.MHI2016-09-24
00848838026874NAREMEL, INC.MHI2016-09-24
00848838026881NAREMEL, INC.MHI2016-09-24
00848838026997NAOXOID LIMITEDMHI2016-09-24
00848838027000NAOXOID LIMITEDMHI2016-09-24
00848838027017NAOXOID LIMITEDMHI2016-09-24
20613647000308Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.MHI2016-09-24
00893038002180Triage®Alere San Diego, Inc.MHI2016-09-21
M445MCCCGDFA750Para-Tect Cryptosporidium/Giardia Direct Fluorescence AssayMEDICAL CHEMICAL CORPORATIONMHI2016-09-20
05391516746328Trinity BiotechMARDX DIAGNOSTICS, INC.MHI2016-09-18
05391516746335Trinity BiotechMARDX DIAGNOSTICS, INC.MHI2016-09-18
20885380096737CARDINAL HEALTHCardinal Health 200, LLCMHI2016-09-14
50885380096738CARDINAL HEALTHCardinal Health 200, LLCMHI2016-09-14
00857031002028GIARDIA IITECHLAB, INC.MHI2016-08-23
00857031002295GIARDIA IITECHLAB, INC.MHI2016-08-23