FDA.reportPublic FDA data

Chemstrip 5 OB Test Strips

Primary DI
00075537018934
Brand
Chemstrip 5 OB Test Strips
Company
Roche Diagnostics GmbH
Model
11893467160
Catalog number
11893467160
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
CDMDIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CDMDiazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)Clinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K032437000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032437000CHEMSTRIP 5 OB, CHEMSTRIP 7 AND CHEMSTRIP 10 MD TEST STRIPSRoche Diagnostics Corp.2003-10-08JIL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00075537018934PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00075537018934000755370189340755370189340075537018934

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
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

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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06935740751780URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.CDM2026-06-03
06935740751797URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.CDM2026-06-03
06935740751803Urine StripsUrit Medical Electronic Co., Ltd.CDM2026-06-03
06935740751810Urine StripsUrit Medical Electronic Co., Ltd.CDM2026-06-03
06935740751827URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.CDM2026-06-03
06935740751834Urine StripsUrit Medical Electronic Co., Ltd.CDM2026-06-03
06935740751841Urine AnalyzerUrit Medical Electronic Co., Ltd.CDM2026-06-03
06935740751858Urine AnalyzerUrit Medical Electronic Co., Ltd.CDM2026-06-03
06935740751865URINE ANALYZERUrit Medical Electronic Co., Ltd.CDM2026-06-03
06935740751872URINE ANALYZERUrit Medical Electronic Co., Ltd.CDM2026-06-03
06935740750608Urine Reagent StripsUrit Medical Electronic Co., Ltd.CDM2026-04-16
06935740750615Urine Reagent StripsUrit Medical Electronic Co., Ltd.CDM2026-04-16
06935740750738Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.CDM2026-04-16
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20682607200492Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.CDM2026-02-06
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20682607200911Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.CDM2026-02-06
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00850054026729QMedix™Diagnostic Automation, Inc.CDM2024-10-29
06935740733755Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.CDM2024-06-14
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10673486000498Teco Diagnostics Uritek TC-720+ Urine Chemistry Test SystemTECO DIAGNOSTICSCDM2024-06-05
10673486000511Teco Diagnostics Uritek TC-201 Urine Chemistry Test SystemTECO DIAGNOSTICSCDM2024-06-04
08806141303497One+Step 10ADFI CO.,LTDCDM2023-10-16
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