FDA.reportPublic FDA data

Fisherbrand

Primary DI
00613647008850
Brand
Fisherbrand
Company
FISHER SCIENTIFIC COMPANY L.L.C.
Model
51100
Catalog number
23111262
Device description
URINE RGNT STRIP 10SG 100/PK
Published
2022-11-29
Public version status
New
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
CDMDIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CDMDiazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20613647008854PackageGS11In Commercial Distribution
30613647008851PackageGS124In Commercial Distribution
00613647008850PrimaryGS10
10613647008857Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2061364700885420613647008854
3061364700885130613647008851
00613647008850006136470088506136470088500613647008850
1061364700885710613647008857

GMDN Terms#

Term, Definition table
TermDefinition
Urine catalase IVD, kit, rapid colorimetric, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative screening of urine for catalase within a short period relative to standard laboratory testing procedures, using a rapid colorimetric 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.

Contacts#

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

Regulatory Flags#

DUNS number
004321519
Device count
100
DM exempt
true
Premarket 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
06935740751773Urine StripsUrit Medical Electronic Co., Ltd.CDM2026-06-03
06935740751780URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.CDM2026-06-03
06935740751797URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.CDM2026-06-03
06935740751803Urine StripsUrit Medical Electronic Co., Ltd.CDM2026-06-03
06935740751810Urine StripsUrit Medical Electronic Co., Ltd.CDM2026-06-03
06935740751827URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.CDM2026-06-03
06935740751834Urine StripsUrit Medical Electronic Co., Ltd.CDM2026-06-03
06935740751841Urine AnalyzerUrit Medical Electronic Co., Ltd.CDM2026-06-03
06935740751858Urine AnalyzerUrit Medical Electronic Co., Ltd.CDM2026-06-03
06935740751865URINE ANALYZERUrit Medical Electronic Co., Ltd.CDM2026-06-03
06935740751872URINE ANALYZERUrit Medical Electronic Co., Ltd.CDM2026-06-03
06935740750608Urine Reagent StripsUrit Medical Electronic Co., Ltd.CDM2026-04-16
06935740750615Urine Reagent StripsUrit Medical Electronic Co., Ltd.CDM2026-04-16
06935740750738Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.CDM2026-04-16
20682607200485Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.CDM2026-02-06
20682607200492Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.CDM2026-02-06
20682607200904Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.CDM2026-02-06
20682607200911Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.CDM2026-02-06
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.CDM2025-09-18
00850054026729QMedix™Diagnostic Automation, Inc.CDM2024-10-29
06935740733755Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.CDM2024-06-14
10673486000528Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer SystemTECO DIAGNOSTICSCDM2024-06-06
10673486000498Teco Diagnostics Uritek TC-720+ Urine Chemistry Test SystemTECO DIAGNOSTICSCDM2024-06-05
10673486000511Teco Diagnostics Uritek TC-201 Urine Chemistry Test SystemTECO DIAGNOSTICSCDM2024-06-04
08806141303497One+Step 10ADFI CO.,LTDCDM2023-10-16
00657498002094Uri-Trak 120 M Urine AnalyzerSTANBIO LABORATORY, L.P.CDM2023-06-08
10884389181911MedlineMEDLINE INDUSTRIES, INC.CDM2022-12-10
20613647008854FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.CDM2022-11-29
10884389181973MedlineMEDLINE INDUSTRIES, INC.CDM2022-04-13
10884389181959MedlineMEDLINE INDUSTRIES, INC.CDM2021-09-16