2-Compnent DAB Pack HK542-XAKE

GUDID 00850646007365

BIOGENEX LABORATORIES

Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistry
Primary Device ID00850646007365
NIH Device Record Key87fae5bb-d9e6-47e0-b5f5-479a13c5d814
Commercial Distribution StatusIn Commercial Distribution
Brand Name2-Compnent DAB Pack
Version Model NumberHK542-XAKE
Catalog NumberHK542-XAKE
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 (800) 421-4149
Emailsupport@biogenex.com
Phone+1 (800) 421-4149
Emailsupport@biogenex.com
Phone+1 (800) 421-4149
Emailsupport@biogenex.com
Phone+1 (800) 421-4149
Emailsupport@biogenex.com
Phone+1 (800) 421-4149
Emailsupport@biogenex.com
Phone+1 (800) 421-4149
Emailsupport@biogenex.com
Phone+1 (800) 421-4149
Emailsupport@biogenex.com
Phone+1 (800) 421-4149
Emailsupport@biogenex.com
Phone+1 (800) 421-4149
Emailsupport@biogenex.com
Phone+1 (800) 421-4149
Emailsupport@biogenex.com
Phone+1 (800) 421-4149
Emailsupport@biogenex.com
Phone+1 (800) 421-4149
Emailsupport@biogenex.com
Phone+1 (800) 421-4149
Emailsupport@biogenex.com
Phone+1 (800) 421-4149
Emailsupport@biogenex.com
Phone+1 (800) 421-4149
Emailsupport@biogenex.com
Phone+1 (800) 421-4149
Emailsupport@biogenex.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at 2-8°C
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 2-8°C
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 2-8°C
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 2-8°C
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 2-8°C
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 2-8°C
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 2-8°C
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 2-8°C
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 2-8°C
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 2-8°C
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 2-8°C
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 2-8°C
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 2-8°C
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 2-8°C
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 2-8°C
Special Storage Condition, SpecifyBetween 0 and 0 *Store at 2-8°C

Device Identifiers

Device Issuing AgencyDevice ID
GS100850646007365 [Primary]

FDA Product Code

NJTImmunohistochemistry Reagents And Kits

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-29
Device Publish Date2023-05-19

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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