FDA.reportPublic FDA data

Urine Standard

Primary DI
00811403016006
Brand
Urine Standard
Company
Diamond Diagnostics Inc.
Model
ME-2577D
Published
2023-06-06
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

Product Codes#

Code, Name table
CodeName
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811403016006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811403016006008114030160068114030160060811403016006

GMDN Terms#

Term, Definition table
TermDefinition
Multiple electrolyte IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of one or multiple electrolytes in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
947514303
Device count
1
DM exempt
false
Premarket exempt
true
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
00811403010158Photometer LampOY-MU8550D2023-06-13
00811403010240Reference SolutionIL-09756904D2023-06-13
00811403013074Pump Tubing KitCD-105673D2023-06-13
00811403013173C1/C2 Cleaning SolutionCD-473389D2023-06-13
00811403010387Wash PackCD-473497D2023-06-13
00811403013296pH ElectrodeCD-476267D2023-06-13
00811403013302Calcium ElectrodeCD-476268D2023-06-13
00811403013319Potassium ElectrodeCD-476270D2023-06-13
00811403013326Reference ElectrodeCD-476273D2023-06-13
00811403013333Chloride ElectrodeCD-476279D2023-06-13
00811403013371Fill SolutionCD-478533D2023-06-13
00811403013388Na-K-Ca-Cl Fill SolutionCD-478535D2023-06-13
00811403013456Conditoner SolutionCD-478701D2023-06-13
00811403013463Reference SolutionCD-478822D2023-06-13
00811403013609Printer PaperCD-67252D2023-06-13
00811403013630Pump TubingCD-673705D2023-06-13
00811403014040Salt Bridge SolutionDA-D105D2023-06-13
00811403014217Quick IMT Sample DiluentDA-S635D2023-06-13
00811403014224Quick IMT Diluent CheckDA-S640D2023-06-13
00811403015504Maintenance KitHM-XEA328ASD2023-06-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336200544cobas c 703 analytical unitRoche Diagnostics GmbHJJE2026-03-20
07613336220191cobas pro SBL c 703Roche Diagnostics GmbHJJE2026-03-20
00199874508153Spiral LaboratoriesSOCIETE ANONYME DE FABRICATION D'APPAREILS SCIENTIFIQUESJJE2026-02-10
00380740023386ARCHITECTABBOTT LABORATORIESJJE2026-01-24
00380740225155ARCHITECTABBOTT LABORATORIESJJE2026-01-03
00380740225162ARCHITECTABBOTT LABORATORIESJJE2026-01-03
00380740223748AlinityAbbott GmbHJJE2026-01-01
00380740224523ARCHITECTABBOTT LABORATORIESJJE2026-01-01
00380740224530ARCHITECTABBOTT LABORATORIESJJE2026-01-01
00380740186241AlinityAbbott GmbHJJE2025-12-19
00380740186258AlinityAbbott GmbHJJE2025-12-19
00380740213398AlinityAbbott GmbHJJE2025-12-19
00380740213404AlinityAbbott GmbHJJE2025-12-19
00380740213411AlinityAbbott GmbHJJE2025-12-19
00380740213428AlinityAbbott GmbHJJE2025-12-19
00380740199074AlinityAbbott GmbHJJE2025-11-27
00380740215224AlinityAbbott GmbHJJE2025-09-29
04260678680010GEMINISTRATEC SEJJE2025-09-05
00380740220556ARCHITECTABBOTT LABORATORIESJJE2025-08-22
00380740220563ARCHITECTABBOTT LABORATORIESJJE2025-08-22
00380740220495ARCHITECTABBOTT LABORATORIESJJE2025-08-02
00380740220501ARCHITECTABBOTT LABORATORIESJJE2025-08-02
05999883586419P780 Clinical Chemistry Analyzer with ISE moduleDiatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagJJE2025-07-10
05999883586426P780 Clinical Chemistry AnalyzerDiatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagJJE2025-07-10
05999883586907Atellica DT Cuvettes (280pcs)Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagJJE2025-06-13
10758750035656VITROSORTHO-CLINICAL DIAGNOSTICS, INC.JJE2025-05-21
03701700860358Viva-ProEVitalScientific B.V.JJE2025-04-30
15999883586744Atellica DT 250 Analyzer Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagJJE2025-04-30
00380740186425AlinityAbbott GmbHJJE2025-04-15
00380740190644ARCHITECTABBOTT LABORATORIESJJE2025-04-15