FDA.reportPublic FDA data

Sure-Vue

Primary DI
10613647000875
Brand
Sure-Vue
Company
FISHER SCIENTIFIC COMPANY L.L.C.
Model
T3018-5551
Catalog number
23038011
Device description
SURE-VUE RPR ANTIGEN 1X9 ML  23-038011
Published
2017-06-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GMPANTISERA, CONTROL FOR NONTREPONEMAL TESTS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GMPAntisera, Control For Nontreponemal TestsMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10613647000875PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1061364700087510613647000875

GMDN Terms#

Term, Definition table
TermDefinition
Treponema pallidum reagin antibody IVD, kit, agglutinationA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of non-specific reagin antibodies that are produced in response to infection with Treponema pallidum bacteria, in a clinical specimen using an agglutination method [for example Rapid Plasma Reagin (RPR) test or Venereal Disease Research Laboratory (VDRL) test]. The assay is designed to detect infection with Treponema pallidum, the bacteria associated with syphilis.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(724)517-2425Regulatory.affairs@thermofisher.com

Regulatory Flags#

DUNS number
004321519
Device count
1
DM exempt
true
Kit
true
Lot or batch
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
00816057021796ASI RPR Card Test for SyphilisARLINGTON SCIENTIFIC, INC.GMP2023-12-19
00816057021802ASI RPR Card Test for SyphilisARLINGTON SCIENTIFIC, INC.GMP2023-12-19
B224V611VDRL CONTROL SERUM KITCENOGENICS CORPORATIONGMP2021-05-27
00613647001585Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.GMP2019-04-18
00613647001592Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.GMP2019-04-18
00613647001608Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.GMP2019-04-18
00613647001615Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.GMP2019-04-18
00613647001622Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.GMP2019-04-18
00613647000977Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.GMP2019-04-08
00613647001578Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.GMP2019-04-08
10613647000837Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.GMP2017-06-27
10613647000844Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.GMP2017-06-27
10613647000851Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.GMP2017-06-27
10613647000868Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.GMP2017-06-27
10613647000882Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.GMP2017-06-27
10613647000899Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.GMP2017-06-27
10613647000905Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.GMP2017-06-27
10613647000912Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.GMP2017-06-27
00816057021659ASI RPR Card Test for Syphilis ARLINGTON SCIENTIFIC, INC.GMP2017-03-16
10885380114403CARDINAL HEALTHCardinal Health 200, LLCGMP2016-09-15
10885380114410CARDINAL HEALTHCardinal Health 200, LLCGMP2016-09-15
20885380114400CARDINAL HEALTHCardinal Health 200, LLCGMP2016-09-15
20885380114417CARDINAL HEALTHCardinal Health 200, LLCGMP2016-09-15
20885380114370CARDINAL HEALTHCardinal Health 200, LLCGMP2016-09-15
20885380114387CARDINAL HEALTHCardinal Health 200, LLCGMP2016-09-15
20885380114394CARDINAL HEALTHCardinal Health 200, LLCGMP2016-09-15
00816057020690ASI RPR Card Test for SyphilisARLINGTON SCIENTIFIC, INC.GMP2016-07-08
00816057020706ASI RPR Card Test for SyphilisARLINGTON SCIENTIFIC, INC.GMP2016-07-08
00816057020713ASI RPR Card Test for SyphilisARLINGTON SCIENTIFIC, INC.GMP2016-07-08
00816057020720ASI RPR Card Test for SyphilisARLINGTON SCIENTIFIC, INC.GMP2016-07-08