FDA.report

Starling Medical, Inc

Primary DI
00860010249017
Brand
Starling Medical, Inc
Company
Starling Medical, Inc.
Model
DW-01206
Device description
Anchor Assembly
Published
2023-05-22
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
false

Related Records

Product Codes

CodeName
JMTDiazo (Colorimetric), Nitrite (Urinary, Non-Quant)

Product Code Classifications

CodeDeviceSpecialtyClass
JMTDiazo (Colorimetric), Nitrite (Urinary, Non-Quant)Clinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00860010249017PrimaryGS10

GMDN Terms

TermDefinition
Multiple urine analyte IVD, kit, rapid colorimetric, self-testingA 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 test is intended to be used for self-testing by a layperson in the home or similar environment to screen for non-microbial markers associated with a urinary tract infection (UTI) [e.g., leukocytes, blood, nitrites, proteins].

Sterilization Methods

Method

Regulatory Flags

DUNS number
117325922
Device count
1
DM exempt
false
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 DIBrandModelCatalogPublished
00860010249000Starling Medical, IncDW-012052023-05-22
00860010249024Starling Medical, IncDW-012072023-05-22

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00810164510624Atida Urinary Tract Infection TestACESO LABORATORIES INC.JMT2026-03-23
10860011489129Vivoo At-Home UTI Test StripsVIVOSENS INC.JMT2026-02-13
20682607200904Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JMT2026-02-06
04987486053002S.G. Calibrator HARKRAY USA, INC.JMT2025-12-19
00860011489146Vivoo At-Home Urinary Tract Infection TestVIVOSENS INC.JMT2024-11-25
20682607651256HealthyMe UTI Urinary Tract Infection Test StripsACON LABORATORIES, INC.JMT2024-03-27
00630414317427Clinistix UTI Test StripsSiemens Healthcare Diagnostics Inc.JMT2024-02-21
10810143620006GenaCheck Rapid Self-Test Kit For Urinary Tract InfectionsGenabio Diagnostics Inc.JMT2023-10-06
00860010249000Starling Medical, IncStarling Medical, Inc.JMT2023-05-22
00860010249024Starling Medical, IncStarling Medical, Inc.JMT2023-05-22
10888277110403MedlineMEDLINE INDUSTRIES, INC.JMT2020-08-21
50885380175549CARDINAL HEALTHCardinal Health 200, LLCJMT2020-06-30
50096295135850LEADERCARDINAL HEALTH, INC.JMT2019-04-18
04987486001959S.G. Calibrator HARKRAY USA, INC.JMT2017-04-12
10673486000405TECO DIAGNOSTICSTECO DIAGNOSTICSJMT2017-01-05
10673486000382TECO DIAGNOSTICSTECO DIAGNOSTICSJMT2017-01-05
10673486000399TECO DIAGNOSTICSTECO DIAGNOSTICSJMT2017-01-05
00722066003404Rapid ResponseBTNX IncJMT2016-10-25
00722066000373Rapid ResponseBTNX IncJMT2016-10-17
10763924410146AccutestJANT PHARMACAL CORPORATIONJMT2016-09-24
00682607000401Mission Urinalysis Reagent StripsACON LABORATORIES, INC.JMT2016-09-24
00682607000678Mission Urinalysis Reagent StripsACON LABORATORIES, INC.JMT2016-09-24
00682607000685Mission Urinalysis Reagent StripsACON LABORATORIES, INC.JMT2016-09-24
20682607200133Mission Urinalysis Reagent StripsACON LABORATORIES, INC.JMT2016-09-24
20682607200225Mission Urinalysis Reagent StripsACON LABORATORIES, INC.JMT2016-09-24
20682607200317Mission Urinalysis Reagent StripsACON LABORATORIES, INC.JMT2016-09-24
20682607200324Mission Urinalysis Reagent StripsACON LABORATORIES, INC.JMT2016-09-24
20682607200331Mission Urinalysis Reagent StripsACON LABORATORIES, INC.JMT2016-09-24
20682607200362Mission Urinalysis Reagent StripsACON LABORATORIES, INC.JMT2016-09-24
00630414549033Multistix® 8 SG Reagent StripsSiemens Healthcare Diagnostics Inc.JMT2016-09-24