FDA.reportPublic FDA data

Fisherbrand

Primary DI
00613647003664
Brand
Fisherbrand
Company
FISHER SCIENTIFIC COMPANY L.L.C.
Model
14377258
Catalog number
14377258
Device description
URISYS CAP OPTIC YELLOW 500/CS
Published
2022-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JXAKIT, SCREENING, URINE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JXAKit, Screening, UrineMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20613647003668PackageGS11In Commercial Distribution
00613647003664PrimaryGS10
10613647003661Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2061364700366820613647003668
00613647003664006136470036646136470036640613647003664
1061364700366110613647003661

GMDN Terms#

Term, Definition table
TermDefinition
Culture tubeA sterile glass or plastic tube-like container used to hold a culture specimen. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
004321519
Device count
500
DM exempt
true
Premarket exempt
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
07290006418111DIASLIDE URINE CULTURING DEVICESAVYON DIAGNOSTICS LTDJXA2026-05-04
07290013348531URISCREEN SAVYON DIAGNOSTICS LTDJXA2026-04-29
50885380070271CARDINAL HEALTHCardinal Health 200, LLCJXA2024-02-28
00860008737359Know Rapid STD TestMobiLab Medical Innovatives Inc.JXA2024-02-06
00860008737304MobiLab Standard Sexual Health Self Rapid TestMobiLab Medical Innovatives Inc.JXA2024-02-05
00613647003596FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
00613647003602FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
00613647003619FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
00613647003626FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
00613647003633FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
00613647003640FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
00613647003657FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
00613647003701FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
00613647003718FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
20613647003590FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
20613647003606FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
20613647003613FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
20613647003620FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
20613647003637FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
20613647003644FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
20613647003651FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
20613647003668FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
00613647003695FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
20613647003705FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
20613647003712FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
03573026600389CHROMID® CPS® Elite Agar (CPSE)BIOMERIEUX SAJXA2020-05-19
03573026600402CHROMID® CPS® Elite Agar (CPSO)BIOMERIEUX SAJXA2020-05-19
03573026600426CHROMID® CPS® Elite agar/Columbia CNA agar + 5% sheep bloodBIOMERIEUX SAJXA2020-05-19
03573026443900CHROMID® CPS® Elite Agar (CPSE)BIOMERIEUX SAJXA2020-05-19
03573026468170CHROMID® CPS® Elite Agar (CPSO)BIOMERIEUX SAJXA2020-05-19