FDA.reportPublic FDA data

Hemastix® Reagent Strips

Primary DI
00630414550596
Brand
Hemastix® Reagent Strips
Company
Siemens Healthcare Diagnostics Inc.
Model
10312568
Catalog number
A2190B16
Device description
HEMASTIX® is a firm plastic strip to which is affixed a reagent area that tests for occult blood in urine. Test results may provide information on urinary tract status.
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
00630414550596PrimaryGS10
00630414009353Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414550596006304145505966304145505960630414550596
00630414009353006304140093536304140093530630414009353

GMDN Terms#

Term, Definition table
TermDefinition
Urine blood IVD, kit, colorimetric, rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative screening of urine for blood within a short period relative to standard laboratory testing procedures, using a colorimetric 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
50
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414596167Atellica CH ASO_211097634110976342020-09-24
00630414596259Atellica CH PreAlb11097617110976172020-09-24
00630414596440Atellica CH GGT11097597110975972020-09-24
00630414596174Atellica CH hsCRP11097633110976332017-12-21
00630414596198Atellica CH CRP_211097631110976312017-12-27
00630414597508Atellica CH hsCRP Calibrator11099412110994122017-12-22
00630414597515Atellica CH CRP_2 Calibrator11099430110994302017-12-22
00630414611075Atellica CH Crea311537215115372152026-05-08
00630414611297Atellica CH RCRP Cal11537245115372452024-02-02
00842768037726Dimension EXL LOCI Troponin I High Sensitive10471068104710682019-10-16
00630414596099Atellica CH Thc11097503110975032017-12-27
00630414510156ADVIA® Chemistry PAMY Pancreatic Amylase Reagents1031517814108202016-09-24
00630414595641Atellica CH PAmy11097622110976222017-12-21
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
00630414653259Atellica CH Crea311537567115375672026-05-08

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