FDA.reportPublic FDA data

Pro Advantage

Primary DI
M220P0800143
Brand
Pro Advantage
Company
NATIONAL DISTRIBUTION & CONTRACTING, INC.
Model
P080014
Catalog number
P080014
Device description
Pro Advantage Urinalysis Reagent Strips 4 Parameter
Published
2017-02-13
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
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
M220P0800145PackageHIBCC24
M220P0800143PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Multiple urine analyte IVD, kit, rapid colorimetric, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of urine for multiple analytes 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 to screen for non-microbial markers associated with a urinary tract infection (UTI) [e.g., leukocytes, blood, nitrites, proteins]. It is not intended to be used for self-testing.

Contacts#

Phone, Email table
PhoneEmail
6153663030compliance@ndc-inc.com

Regulatory Flags#

DUNS number
009831413
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M220P3010088Pro AdvantageP301008P3010082017-02-13
M220P3011058Pro AdvantageP301105P3011052017-02-13
M220P3011158Pro AdvantageP301115P3011152017-02-13
D023Q4000418QualaQ40004Q400042017-02-13
D023Q400042ML1QualaQ400042MLQ400042ML2017-04-25
D023Q400122ML19QualaQ400122MLQ400122ML2017-10-18
D023Q4003017QualaQ40030Q400302017-02-13
D23Q4001217QualaQ40012Q400122017-02-13
M2207250003Pro Advantage72000720002025-09-11
M220761002Pro Advantage76100761002025-09-11
M220762002Pro Advantage76200762002025-09-11
M220767000Pro Advantage76700767002025-09-11
M220768001Pro Advantage76800768002025-09-11
M220768011Pro Advantage76801768012025-09-11
M220769000Pro Advantage76900769002025-09-11
M220770001Pro Advantage77000770002025-09-11
M220771001Pro Advantage77100771002025-09-11
M220720005Pro Advantage72000720002025-09-11
M220761003Pro Advantage76100761002025-09-11
M220762003Pro Advantage76200762002025-09-11

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
00613647008850FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.CDM2022-11-29
20613647008854FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.CDM2022-11-29
10884389181973MedlineMEDLINE INDUSTRIES, INC.CDM2022-04-13