FDA.reportPublic FDA data

Pro Advantage

Primary DI
M220P0800145
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
OTC
false
Sterile
false
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, colorimetric dipstick, rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative screening of urine for multiple analytes within a short period relative to standard laboratory testing procedures, using a colorimetric dipstick method. This test is commonly used in the laboratory or in point-of-care analyses.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
009831413
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
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
06935740751568Fully-Automated Urine Chemistry AnalyzerUrit Medical Electronic Co., Ltd.CDM2026-06-26
06935740751575Urine Chemistry StripsUrit Medical Electronic Co., Ltd.CDM2026-06-26
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