FDA.reportPublic FDA data

Total Protein Urine/CSF Gen.3

Primary DI
07613336121535
Brand
Total Protein Urine/CSF Gen.3
Company
Roche Diagnostics GmbH
Model
08058679190
Catalog number
08058679190
Published
2020-03-05
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
K141925000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141925000TOTAL PROTEIN URINE/CSF GEN.3Roche Diagnostics Operations (Rdo)2014-12-09JIQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613336121535PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613336121535076133361215357613336121535

GMDN Terms#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 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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07613336203606Elecsys Anti-HBc II09014918160090149181602022-04-11
07613336203613Elecsys Anti-HBc II09014926160090149261602022-04-11
04015630938858Elecsys AntiHAV IgM11820591160118205911602016-09-20
04015630939855Elecsys Anti-HAV IgM07026773190070267731902017-09-07
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20875197004766cobas&#x00AE MPX (96 tests)06998909190069989091902017-02-14
00875197004779cobas&#x00AE MPX (480 tests)06998917190069989171902017-02-14
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04015630926091Testosterone II CalSet II05202230190052022301902026-02-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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04015630919536Total Protein UrineCSF Gen3Roche Diagnostics GmbHJGQ2016-09-20
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