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Total Protein UrineCSF Gen3

Primary DI
04015630919536
Brand
Total Protein UrineCSF Gen3
Company
Roche Diagnostics GmbH
Model
3333825190
Catalog number
3333825190
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
JGQTURBIDIMETRIC, TOTAL PROTEIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JGQTurbidimetric, Total ProteinClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071239000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071239000TOTAL PROTEIN URINE/CSF GEN.3Roche Diagnostics2007-09-14JGQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630919536PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630919536040156309195364015630919536

GMDN Terms#

Term, Definition table
TermDefinition
Total protein IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of total protein in a clinical specimen, using an enzyme spectrophotometry method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

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
00380740161798ARCHITECTAbbott GmbHJGQ2020-04-18
00380740161804ARCHITECTAbbott GmbHJGQ2020-04-18
07613336121535Total Protein Urine/CSF Gen.3Roche Diagnostics GmbHJGQ2020-03-05
00380740135317AlinityAbbott GmbHJGQ2019-05-07
00380740135300AlinityAbbott GmbHJGQ2018-11-07
04015630925179Total Protein UrineCSF Gen3Roche Diagnostics GmbHJGQ2016-09-20
04015630936441Protein Total Protein in UrineCerebrospinal FluidRoche Diagnostics GmbHJGQ2016-09-20
00845275003239Thermo Scientific Infinity™Fisher DiagnosticsJGQ2016-09-16
00380740013028ARCHITECTABBOTT LABORATORIESJGQ2016-09-09
00380740013035ARCHITECTABBOTT LABORATORIESJGQ2016-06-06