UNION Immune Analyzer U6103

GUDID 06925912711117

Shenzhen YHLO Biotech Co., Ltd.

Enzyme immunoassay (EIA) analyser IVD
Primary Device ID06925912711117
NIH Device Record Key9ae006ff-cbc1-448e-819e-b11fa72bd409
Commercial Distribution StatusIn Commercial Distribution
Brand NameUNION Immune Analyzer
Version Model NumberUNION-C
Catalog NumberU6103
Company DUNS420735989
Company NameShenzhen YHLO Biotech Co., Ltd.
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 Datetrue
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
GS106925912711117 [Primary]

FDA Product Code

JJEAnalyzer, Chemistry (Photometric, Discrete), 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 Date2022-11-03
Device Publish Date2022-10-26

Devices Manufactured by Shenzhen YHLO Biotech Co., Ltd.

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06925912718833 - iFlash-Anti-Beta2-Glycoprotein I2024-01-08 "Beta" is identical to the second letter of Greek alphabet. Because GUDID system couldn't recognize this letter, it is replaced
06925912708506 - Reaction vessel2022-11-03 2000 pcs/box (2 bag/box, 1000 pcs/bag)
06925912710424 - Chemiluminescence Immunoassay Analyzer2022-11-03 Type A
06925912710462 - Chemiluminescence Immunoassay Analyzer2022-11-03 Type B
06925912710509 - Chemiluminescence Immunoassay Analyzer2022-11-03 Type C
06925912710547 - Chemiluminescence Immunoassay Analyzer2022-11-03 Type D
06925912710578 - Chemiluminescence Immunoassay Analyzer2022-11-03

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