FDA.reportPublic FDA data

Urisys 2400 Calibration strip

Primary DI
04015630004683
Brand
Urisys 2400 Calibration strip
Company
Roche Diagnostics GmbH
Model
3012590061
Catalog number
3012590061
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
JIOBLOOD, OCCULT, COLORIMETRIC, IN URINE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JIOBlood, Occult, Colorimetric, In UrineHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K012397000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012397000URISYS 2400 URINE TEST STRIPRoche Diagnostics Corp.2001-09-26JIL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630004683PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630004683040156300046834015630004683

GMDN Terms#

Term, Definition table
TermDefinition
Multiple-type clinical chemistry analyte profile IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of multiple types of clinical chemistry analytes (e.g., combination of electrolytes, hormones, and proteins) in a clinical specimen, which contribute to or create a full general biochemistry profile.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315028860
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613336217702Elecsys T309744975190097449751902026-09-04
07613336246672Elecsys Anti-HBc II09745009160097450091602026-09-04
07613336172827Elecsys DHEA-S II09043551190090435511902026-08-07
07613336172834Elecsys DHEA-S II09043560190090435601902026-08-07
07613336172841CalSet DHEA-S II09043586190090435861902026-08-07
07613336217696Elecsys Tg II09744967190097449671902026-08-07
07613336217764Elecsys Anti-Tg09745602190097456021902026-08-07
07613336223321Kidney KFRE Algorithm09891986001098919860012025-03-31
07613336234457PreciControl Syphilis09465022190094650221902026-05-15
04015630913893AMYP Amylase EPS Pancreatic20766623322207666233222016-09-20
04015630910991alpha-Amylase liquid acc. to IFCC11876473316118764733162016-09-20
04015630911004Pancreatic alpha-amylase liquid11876562316118765623162016-09-20
04015630926848alpha-Amylase EPS Pancreatic540177119054017711902016-09-20
07613336121016a-Amylase EPS Pancreatic08056820190080568201902020-03-05
07613336171509Elecsys Calcitonin09005676190090056761902026-06-01
07613336171516CalSet Calcitonin09005684190090056841902026-06-01
07613336188064Elecsys Calcitonin09005668160090056681602026-06-01
07613336217641Elecsys Anti-TSHR09744819190097448191902026-06-01
07613336218341Elecsys CA 19-909755608190097556081902026-06-01
07613336218389Elecsys Estradiol III09755659190097556591902026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935740751568Fully-Automated Urine Chemistry AnalyzerUrit Medical Electronic Co., Ltd.JIO2026-06-26
06935740751575Urine Chemistry StripsUrit Medical Electronic Co., Ltd.JIO2026-06-26
06935740751773Urine StripsUrit Medical Electronic Co., Ltd.JIO2026-06-03
06935740751780URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIO2026-06-03
06935740751797URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIO2026-06-03
06935740751803Urine StripsUrit Medical Electronic Co., Ltd.JIO2026-06-03
06935740751810Urine StripsUrit Medical Electronic Co., Ltd.JIO2026-06-03
06935740751827URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIO2026-06-03
06935740751834Urine StripsUrit Medical Electronic Co., Ltd.JIO2026-06-03
06935740751841Urine AnalyzerUrit Medical Electronic Co., Ltd.JIO2026-06-03
06935740751858Urine AnalyzerUrit Medical Electronic Co., Ltd.JIO2026-06-03
06935740751865URINE ANALYZERUrit Medical Electronic Co., Ltd.JIO2026-06-03
06935740751872URINE ANALYZERUrit Medical Electronic Co., Ltd.JIO2026-06-03
06935740750608Urine Reagent StripsUrit Medical Electronic Co., Ltd.JIO2026-04-16
06935740750615Urine Reagent StripsUrit Medical Electronic Co., Ltd.JIO2026-04-16
06935740750738Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.JIO2026-04-16
20682607200485Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JIO2026-02-06
20682607200492Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JIO2026-02-06
20682607200904Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JIO2026-02-06
20682607200911Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JIO2026-02-06
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.JIO2025-09-18
00850054026729QMedix™Diagnostic Automation, Inc.JIO2024-10-29
06935740733755Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.JIO2024-06-14
10673486000528Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer SystemTECO DIAGNOSTICSJIO2024-06-06
10673486000498Teco Diagnostics Uritek TC-720+ Urine Chemistry Test SystemTECO DIAGNOSTICSJIO2024-06-05
10673486000511Teco Diagnostics Uritek TC-201 Urine Chemistry Test SystemTECO DIAGNOSTICSJIO2024-06-04
00657498002094Uri-Trak 120 M Urine AnalyzerSTANBIO LABORATORY, L.P.JIO2023-06-08
40612479183627McKessonMCKESSON MEDICAL-SURGICAL INC.JIO2022-07-28
10884389181973MedlineMEDLINE INDUSTRIES, INC.JIO2022-04-13
10884389181959MedlineMEDLINE INDUSTRIES, INC.JIO2021-09-16