FDA.reportPublic FDA data

Sure-Vue

Primary DI
00613647000304
Brand
Sure-Vue
Company
FISHER SCIENTIFIC COMPANY L.L.C.
Model
23-200-277
Catalog number
23200277
Device description
Sure-Vue Signature Cryptosporidium and Giardia Test Kit
Published
2016-09-24
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
20613647000308PackageGS112In Commercial Distribution
00613647000304PrimaryGS10
10613647000301Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2061364700030820613647000308
00613647000304006136470003046136470003040613647000304
1061364700030110613647000301

GMDN Terms#

Term, Definition table
TermDefinition
Multiple faecal parasite antigen IVD, kit, rapid ICT, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from multiple faecal parasites (e.g., Giardia, Entamoeba and Cryptosporidium species) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

Contacts#

Phone, Email table
PhoneEmail
+018007667000Regulatory.Affairs@thermofisher.com

Regulatory Flags#

DUNS number
004321519
Device count
30
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00613647028346Fisherbrand11002204110022042025-06-30
00613647028674Fisherbrand13-711-274MD13711274MD2025-06-30
00613647028681Fisherbrand13-711-336MD13711336MD2025-06-30
00613647028698Fisherbrand13-711-5AMMD137115AMMD2025-06-30
00613647028711Fisherbrand13-711-9AMMD137119AMMD2025-06-30
20613647028340Fisherbrand11002204110022042025-06-30
20613647028678Fisherbrand13-711-274MD13711274MD2025-06-30
20613647028685Fisherbrand13-711-336MD13711336MD2025-06-30
30613647028699Fisherbrand13-711-5AMMD137115AMMD2025-06-30
30613647028712Fisherbrand13-711-9AMMD137119AMMD2025-06-30
00613647029855Fisherbrand121011F2141270512025-06-30
00613647029862Fisherbrand120953F141275542025-06-30
00613647010907FisherbrandSC-150-100135001002025-04-30
00613647010914FisherbrandSC-180-100135001012025-04-30
00613647010921FisherbrandSC-220-100135001022025-04-30
00613647010938FisherbrandSC-250-100135001032025-04-30
00613647018842Fisherbrand23101000231010002025-04-30
00613647018859Fisherbrand23101001231010012025-04-30
00613647018866Fisherbrand23101002231010022025-04-30
00613647018873Fisherbrand23101003231010032025-04-30

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
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
00840733101113MERIFLUOR Cryptosporidium/GiardiaMERIDIAN BIOSCIENCE, INC.MHI2016-09-23
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