iFlash 9000 CLIA Analyzer FG0076

GUDID 06925912715221

Type A, Standard

Shenzhen YHLO Biotech Co., Ltd.

Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD Chemiluminescent immunoassay analyser IVD

Primary Device ID	06925912715221
NIH Device Record Key	f147047f-ad8d-4269-9ff1-bb28e7f82b58
Commercial Distribution Status	In Commercial Distribution
Brand Name	iFlash 9000 CLIA Analyzer
Version Model Number	iFlash 9000-A
Catalog Number	FG0076
Company DUNS	420735989
Company Name	Shenzhen YHLO Biotech Co., Ltd.
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06925912715221 [Primary]

FDA Product Code

JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2022-11-03
Device Publish Date	2022-10-26

On-Brand Devices [iFlash 9000 CLIA Analyzer]

06925912718154	Type A, autoload
06925912715221	Type A, Standard