FDA.reportPublic FDA data

Sure-Vue

Primary DI
00006136471219
Brand
Sure-Vue
Company
FISHER SCIENTIFIC COMPANY L.L.C.
Model
T3018-4001
Catalog number
23038004
Device description
SURE-VUE RUBELLA 100TST/PK
Published
2017-10-27
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
LQNLATEX AGGLUTINATION ASSAY, RUBELLA

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LQNLatex Agglutination Assay, RubellaMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K896433000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K896433000MODIFIED RUBAGENBiokit USA, Inc.1989-11-29LQN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00006136471219PrimaryGS10
10613647001216Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00006136471219000061364712190061364712190006136471219
1061364700121610613647001216

GMDN Terms#

Term, Definition table
TermDefinition
Rubella virus total antibody IVD, kit, rapid agglutination, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of total antibodies to Rubella virus in a clinical specimen within a short period, relative to standard laboratory testing procedures, using a rapid agglutination method. This is a rapid test commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Fahrenheit8 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
004321519
Device count
100
DM exempt
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
00006136471226Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.LQN2017-10-27
00006136471233Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.LQN2017-10-27
00006136471240Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.LQN2017-10-27
00613647001219Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.LQN2016-09-24
00613647001226Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.LQN2016-09-24
00613647001233Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.LQN2016-09-24
00613647001240Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.LQN2016-09-24
08426950590569Rubagen 100 TESTSBIOKIT, S.A.LQN2016-09-23
08426950590576Rubajet 100 TESTSBIOKIT, S.A.LQN2016-09-23
08426950590583Rubajet 500 TESTSBIOKIT, S.A.LQN2016-09-23
20885380020183CARDINAL HEALTHCardinal Health 200, LLCLQN2016-09-15
20885380020190CARDINAL HEALTHCardinal Health 200, LLCLQN2016-09-15
20885380020206CARDINAL HEALTHCardinal Health 200, LLCLQN2016-09-15
00816057020423ASI Rubella TestARLINGTON SCIENTIFIC, INC.LQN2016-07-08
00816057020430ASI Rubella TestARLINGTON SCIENTIFIC, INC.LQN2016-07-08
00816057020447ASI Rubella TestARLINGTON SCIENTIFIC, INC.LQN2016-07-08
00816057020454ASI Rubella TestARLINGTON SCIENTIFIC, INC.LQN2016-07-08
00816057021635ASI Rubella Test Control SetARLINGTON SCIENTIFIC, INC.LQN2016-07-08