Excyte 20 EX-10318

GUDID 03661540304415

Automated Erythrocyte Sedimentation Rate (ESR) Analyzer

ELITECHGROUP INC.

Erthrocyte sedimentation rate (ESR) analyser IVD
Primary Device ID03661540304415
NIH Device Record Key53a5faa4-0f74-4a6d-92a9-22ad2039e52e
Commercial Distribution StatusIn Commercial Distribution
Brand NameExcyte 20
Version Model Number20 (8 mm)
Catalog NumberEX-10318
Company DUNS052423787
Company NameELITECHGROUP INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103661540304415 [Primary]

FDA Product Code

GKBDevice, Automated Sedimentation Rate

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2022-09-16
Device Publish Date2018-12-26

On-Brand Devices [Excyte 20]

03661540304422Automated Erythrocyte Sedimentation Rate (ESR) Analyzer
03661540304415Automated Erythrocyte Sedimentation Rate (ESR) Analyzer

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.