Sysmex UF1000i, Automated Urine Particle Analyzer with Urinalysis WAM Software

GUDID 00664369000639

Fully Automated Urine Cell Analyzer UF-1000i UF WAM

Sysmex America, Inc.

Flow cytometry analyser IVD, automated Flow cytometry analyser IVD, automated Flow cytometry analyser IVD Flow cytometry analyser IVD Flow cytometry analyser IVD Flow cytometry analyser IVD Flow cytometry analyser IVD Flow cytometry analyser IVD Flow cytometry analyser IVD Flow cytometry analyser IVD Flow cytometry analyser IVD Flow cytometry analyser IVD Flow cytometry analyser IVD Flow cytometry analyser IVD Flow cytometry analyser IVD Flow cytometry analyser IVD
Primary Device ID00664369000639
NIH Device Record Key2a99a7ea-493b-4efe-8777-2aba62fc0430
Commercial Distribution StatusIn Commercial Distribution
Brand NameSysmex UF1000i, Automated Urine Particle Analyzer with Urinalysis WAM Software
Version Model NumberUF-1000i with UF WAM
Company DUNS021860424
Company NameSysmex America, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100664369000639 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LKMCOUNTER, URINE PARTICLE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-04

Devices Manufactured by Sysmex America, Inc.

00664369000851 - Caresphere Workflow Solution2022-12-15
00664369000639 - Sysmex UF1000i, Automated Urine Particle Analyzer with Urinalysis WAM Software2018-07-06Fully Automated Urine Cell Analyzer UF-1000i UF WAM
00664369000639 - Sysmex UF1000i, Automated Urine Particle Analyzer with Urinalysis WAM Software2018-07-06 Fully Automated Urine Cell Analyzer UF-1000i UF WAM

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