AcfS Detection Robot 07759363001

GUDID 07613336172360

Roche Molecular Systems, Inc.

Pipetting system IVD
Primary Device ID07613336172360
NIH Device Record Keya656e723-69ec-4316-8098-db0e23aa0483
Commercial Distribution StatusIn Commercial Distribution
Brand NameAcfS Detection Robot
Version Model Number07759363001
Catalog Number07759363001
Company DUNS117676383
Company NameRoche Molecular Systems, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107613336172360 [Primary]

FDA Product Code

JQWSTATION, PIPETTING AND DILUTING, FOR CLINICAL USE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-02-07
Device Publish Date2025-01-30

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