i6000™ Infinity AS6040

GUDID 00810119676320

BIOGENEX LABORATORIES

Microscope slide stainer IVD
Primary Device ID00810119676320
NIH Device Record Key0f355452-5b48-4d06-b7be-4e00afa1295e
Commercial Distribution StatusIn Commercial Distribution
Brand Namei6000™ Infinity
Version Model NumberAS6040
Catalog NumberAS6040
Company DUNS042697045
Company NameBIOGENEX LABORATORIES
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
GS100810119676320 [Primary]

FDA Product Code

KEYStainer, Tissue, Automated

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-04-28
Device Publish Date2023-04-20

Devices Manufactured by BIOGENEX LABORATORIES

00810119675187 - ANTI-PAX52023-05-29
00810119675972 - ANTI-HLA-DR2023-05-29
00810119676061 - Anti- c-Myc2023-05-29
00810119676221 - LIQUID DAB, CHROMOGEN2023-05-29
00810119676252 - H.PYLORI2023-05-29
00850646007327 - AEC (Aminoethylcarbazole)2023-05-29
00850646007334 - AEC Substrate Pack2023-05-29
00850646007341 - Diluent2023-05-29

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