FDA.reportPublic FDA data

Floodlight MS U-Turn Test

Primary DI
07613336193341
Brand
Floodlight MS U-Turn Test
Company
Roche Molecular Systems, Inc.
Model
09342311001
Catalog number
09342311001
Published
2021-01-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GWWAtaxiagraph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWWAtaxiagraphNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613336193341PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613336193341076133361933417613336193341

GMDN Terms#

Term, Definition table
TermDefinition
Self-care monitoring/reporting softwareAn application software program designed for the continual collection and aggregation of a patient's self-care data to promote communication between patient and healthcare provider, to facilitate a patient's self-care by using rules defined during use of the application, and/or to facilitate population monitoring. It is typically used to capture clinical (e.g., blood pressure, weight, and blood glucose), nutritional, and/or exercise information in the home, which may include medication administration information captured from enabled injection devices and data from wearable devices, providing care plan, journal, medication advice, and/or messaging functionalities.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117676383
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613336231098Opulus Lymphoma Precision10257873001102578730012026-05-08
00875197006476cobas® HBV/HCV/HIV-1 Control Kit09040773190090407731902021-12-10
00875197004014cobas® TaqScreen MPX Control Kit, v2.02.0059653901902015-02-20
00875197001068COBAS® AmpliScreen HCV Test, v2.02033025630182014-09-17
00875197001099COBAS® AmpliScreen HIV-1 Test, v1.52033221140182014-09-09
00875197001662cobas® TaqScreen MPX Test04584252190045842521902014-09-17
00875197002102COBAS® AmpliScreen HBV Test03599779190035997791902014-09-17
00875197004045cobas® TaqScreen MPX Test, v2.02.0059694841902015-02-20
07613336206355cobas® 6800 system09575154001095751540012026-03-26
07613336206362cobas® 8800 system09575146001095751460012026-03-26
00875197007459cobas® Liat Transfer Pipette Pack10383852190103838521902026-03-26
00875197005240cobas® Cdiff Test06768237190067682371902026-02-24
00875197005288cobas® 4800 Cdiff Controls and Cofactor Kit06768300190067683001902026-02-24
00875197006056cobas® TV/MG08017450190080174501902026-02-24
00875197006063cobas® TV/MG Positive Control Kit07948689190079486891902026-02-24
00875197006377cobas® SARS-CoV-2 & Influenza A/B Quality Control Kit09211128190092111281902026-02-24
00875197006742cobas SARS-CoV-209408592190094085921902026-02-24
00875197006759cobas SARS-CoV-2 Quality Control Kit09408835190094088351902026-02-24
00875197006902cobas® TV/MG09040633190090406331902026-02-24
00875197006919cobas® TV/MG Positive Control Kit09040641190090406411902026-02-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809209590938InBodyInBody Co., Ltd.GWW2023-06-22
07613336193242Floodlight MS Pinching TestRoche Molecular Systems, Inc.GWW2021-01-15
07613336193259Floodlight MS Pinching Test Roche Molecular Systems, Inc.GWW2021-01-15
07613336193280Floodlight MS Draw Shape TestRoche Molecular Systems, Inc.GWW2021-01-15
07613336193297Floodlight MS Draw Shape TestRoche Molecular Systems, Inc.GWW2021-01-15
07613336193334Floodlight MS U-Turn TestRoche Molecular Systems, Inc.GWW2021-01-15