FDA.reportPublic FDA data

Labstix® Reagent Strips

Primary DI
00630414549101
Brand
Labstix® Reagent Strips
Company
Siemens Healthcare Diagnostics Inc.
Model
10337069
Catalog number
A2181B16
Device description
Siemens Healthcare Diagnostics Reagent Strips for Urinalysis include test pads for protein, blood, glucose, ketone (aceto-acetic acietic acid) and pH
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

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
K905396000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K905396000HEMASTIX REAGENT STRIPSHeraeus Kulzer, Inc.1991-02-11JIO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414549101PrimaryGS10
00630414009674Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414549101006304145491016304145491010630414549101
00630414009674006304140096746304140096740630414009674

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not store in direct sunlight.
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)229-3711XX@XX.XX
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
064608573
Device count
100
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414608273ADVIA Centaur Tumor Marker Quality Control (TM QC)11538186115381862026-05-29
00630414622859Atellica IM Tumor Marker Quality Control (TM QC)11538187115381872026-05-29
00630414517681ADVIA® Chemistry ASO_2 Anti-Streptolysin-O_2 Reagents1031820830554832020-09-24
00842768016912Dimension® PBNP Calibrator10445008RC423A2016-09-24
00630414498942ADVIA® Chemistry ACET Acetaminophen Reagents1032738179891382016-09-24
00630414568768ADVIA® Chemistry BENZ_2 Benzodiazepine_2 Reagents10378760103787602016-09-24
00630414611075Atellica CH Crea311537215115372152026-05-08
00630414653259Atellica CH Crea311537567115375672026-05-08
00630414618456ADVIA CENTAUR ELF MCM SET11208709112087092023-03-15
00630414506005ADVIA® Chemistry HAPT Haptoglobin Reagents103141648310082016-09-24
00630414595795Atellica CH ECre_211097533110975332017-12-22
00842768015281Dimension Vista® Flex® reagent cartridge LIDO10445132K41132016-09-24
00630414291338ADVIA Centaur Cytokeratin Fragment 21-1 (CYFRA)11354590113545902026-04-16
00630414291345Atellica IM CYFRA 21-111354591113545912026-04-16
00630414292779Siemens Healthineers CYFRA 21-1 MCM11536187115361872026-04-16
00630414292786Atellica IM CYFRA 21-1 MCM11536188115361882026-04-16
00630414611693ADVIA Centaur Cytokeratin Fragment 21-1 Calibrator (CYFRA CAL)11553956115539562026-04-16
00630414622804Atellica IM CYFRA21-1 Calibrator11553957115539572026-04-16
00630414654041Atellica CH Ca11645759116457592026-04-08
00630414654102Atellica CH ALP_2c11645758116457582026-04-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00722066005255Rapid ResponseBTNX IncJIO2020-12-14
08806141302209Just Fitter 10 Parameter Test Strips DFI CO.,LTDJIO2020-09-22
10888277110403MedlineMEDLINE INDUSTRIES, INC.JIO2020-08-21
10885380175589CARDINAL HEALTHCardinal Health 200, LLCJIO2020-07-09
20885380175548CARDINAL HEALTHCardinal Health 200, LLCJIO2020-06-30
20885380175555CARDINAL HEALTHCardinal Health 200, LLCJIO2020-06-30
20885380175579CARDINAL HEALTHCardinal Health 200, LLCJIO2020-06-30
08806141302070CYBOW 10DFI CO.,LTDJIO2020-06-29
10673486000672TECO DIAGNOSTICSTECO DIAGNOSTICSJIO2020-03-09
08806141301998Yodoc 10DFI CO.,LTDJIO2020-02-20
00722066001219Rapid ResponseBTNX IncJIO2019-10-16
00722066001936Rapid ResponseBTNX IncJIO2019-10-16
06945040104780CONTECContec Medical Systems Co., Ltd.JIO2019-09-10