FDA.reportPublic FDA data

Fisherbrand

Primary DI
20613647003712
Brand
Fisherbrand
Company
FISHER SCIENTIFIC COMPANY L.L.C.
Model
14-375-246
Catalog number
14375246
Device description
FSH URINALYSIS SYSTEM 500/CS
Published
2022-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
20613647003712PackageGS11In Commercial Distribution
00613647003718PrimaryGS10
10613647003715Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2061364700371220613647003712
00613647003718006136470037186136470037180613647003718
1061364700371510613647003715

GMDN Terms#

Term, Definition table
TermDefinition
Urine specimen collection kit IVDA collection of noninvasive devices intended to be used for the collection, preservation, and transport of a urine specimen for culture, analysis, and/or other investigation. It typically consists of a primary urine collection receptacle (e.g., cup, conical tube, vessel), a urine preservation/transport tube [typically evacuated, with or without additives], and a transfer device for facilitating the aseptic transfer of a urine sample between receptacles; supportive devices for urine collection (e.g., wet wipes, absorbent pads, Foley catheter connector) and/or analysis [e.g., microscope slides, tube rack] may also be included in the kit. This is a single-use device.

Sterilization Methods#

Method table
Method

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
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00613647003664FisherbrandFISHER 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
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