ANTI-HSA AM550-5M

GUDID 00810119670830

BIOGENEX LABORATORIES

Hepatocyte specific antigen IVD, antibody
Primary Device ID00810119670830
NIH Device Record Key34354435-79fb-418e-941d-bd2277f54b1b
Commercial Distribution StatusIn Commercial Distribution
Brand NameANTI-HSA
Version Model NumberAM550-5M
Catalog NumberAM550-5M
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

Device Dimensions

Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100810119670830 [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 Date2023-05-19
Device Publish Date2023-05-11

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

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