FDA.reportPublic FDA data

Detector UA 10

Primary DI
20722355002204
Brand
Detector UA 10
Company
IMMUNOSTICS COMPANY, INC
Model
IDU-10
Device description
Urine Reagent Strips (URS) for Urinalysis are firm plastic strips to which several different reagent areas are affixed
Published
2016-09-26
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
JREREFRACTOMETER FOR CLINICAL USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JRERefractometer For Clinical UseClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K970250000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K970250000CLINISTRIPTeco Diagnostics1997-04-08JIL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20722355002204PackageGS124In Commercial Distribution
10722355002221PrimaryGS10
80722355002220Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2072235500220420722355002204
1072235500222110722355002221
8072235500222080722355002220

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 (strip) method. This test is 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].

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(732)918-0770technical@immunostics.com

Regulatory Flags#

DUNS number
119214195
Device count
100
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
10722355002894hema-screen SPECIFIC GOLDHSGD-25HSGD-252025-04-16
10722355002900hema-screen SPECIFIC GOLDHSGDCAS-25HSGDCAS-252025-04-16
10722355003068hema-screen SPECIFIC GOLDHSGDENV-20HSGDENV-202025-04-16
10722355001002hema-screenHS-502016-09-23
10722355001019hema-screenHS-1002016-09-23
10722355001026hema-screenHS-10002016-09-23
10722355001033hema-screenHS-342016-09-23
10722355001040hema-screenHSPP-502016-09-23
10722355001057hema-screen STATHSTAT-502016-09-23
10722355001071hema-screen SPECIFICHSSP-252016-09-21
10722355001095hema-screen SPECIFICHSSPCAS-252016-09-21
10722355001101hema-screen SPECIFICHSSPENV-202016-09-21
10722355001125hema-screenHSDV-82016-09-23
10722355001255Detector MonoIDM-252016-09-22
10722355001453Detector PersonalIDP-32016-09-20
10722355001668Detector Strep AIST-501-OBC33IDSTREP-252016-09-21
10722355002016Detector H. pyloriIHP-102016-09-22
10722355002023Detector H. pyloriIHP-302016-09-22
10722355002146hema-screen Triple 335HSTR-335CS2016-09-23
10722355002221Detector UA 10IDU-102016-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935740750608Urine Reagent StripsUrit Medical Electronic Co., Ltd.JRE2026-04-16
06935740750615Urine Reagent StripsUrit Medical Electronic Co., Ltd.JRE2026-04-16
06935740750738Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.JRE2026-04-16
20682607200485Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JRE2026-02-06
20682607200492Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JRE2026-02-06
20682607200904Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JRE2026-02-06
20682607200911Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JRE2026-02-06
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.JRE2025-09-18
00812559011495Reichert® Digital USG-ChekREICHERT, INC.JRE2025-08-12
00812559011518Clinical Refractometers Reichert® Digital Clinic-ChekREICHERT, INC.JRE2025-08-12
00850054026729QMedix™Diagnostic Automation, Inc.JRE2024-10-29
06935740733755Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.JRE2024-06-14
10673486000528Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer SystemTECO DIAGNOSTICSJRE2024-06-06
10673486000498Teco Diagnostics Uritek TC-720+ Urine Chemistry Test SystemTECO DIAGNOSTICSJRE2024-06-05
10673486000511Teco Diagnostics Uritek TC-201 Urine Chemistry Test SystemTECO DIAGNOSTICSJRE2024-06-04
00026072023716PCAllied Medical, LLCJRE2023-12-08
08806141303497One+Step 10ADFI CO.,LTDJRE2023-10-16
00657498002094Uri-Trak 120 M Urine AnalyzerSTANBIO LABORATORY, L.P.JRE2023-06-08
10884389181973MedlineMEDLINE INDUSTRIES, INC.JRE2022-04-13
10884389181959MedlineMEDLINE INDUSTRIES, INC.JRE2021-09-16
00722066005255Rapid ResponseBTNX IncJRE2020-12-14
00630414607962Clinitek Status ConnectorSiemens Healthcare Diagnostics Inc.JRE2020-09-30
08806141302209Just Fitter 10 Parameter Test Strips DFI CO.,LTDJRE2020-09-22
10888277110403MedlineMEDLINE INDUSTRIES, INC.JRE2020-08-21
10885380175589CARDINAL HEALTHCardinal Health 200, LLCJRE2020-07-09
20885380175548CARDINAL HEALTHCardinal Health 200, LLCJRE2020-06-30
08806141302070CYBOW 10DFI CO.,LTDJRE2020-06-29
10673486000672TECO DIAGNOSTICSTECO DIAGNOSTICSJRE2020-03-09
08806141301998Yodoc 10DFI CO.,LTDJRE2020-02-20
00722066001219Rapid ResponseBTNX IncJRE2019-10-16