C1 Esterase Inhibitor RID plate package 135411

GUDID B1761354

Radial immunodiffusion plate package for human C1 Esterase Inhibitor

KENT LABORATORIES INC

Complement component C1 inhibitor IVD, kit, precipitation/immunodiffusion Complement component C1 inhibitor IVD, kit, precipitation/immunodiffusion
Primary Device IDB1761354
NIH Device Record Key57fadfd2-f841-4565-87bb-86f4fdcdd854
Commercial Distribution StatusIn Commercial Distribution
Brand NameC1 Esterase Inhibitor RID plate package
Version Model Number1
Catalog Number135411
Company DUNS093642254
Company NameKENT LABORATORIES INC
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

Phone3603988641
Emaildonald@kentlabs.com
Phone3603988641
Emaildonald@kentlabs.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 4 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB1761354 [Primary]

FDA Product Code

JZQPlates And Equipment, Radial Immunodiffusion

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-24

Devices Manufactured by KENT LABORATORIES INC

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B1761212 - Anti Human C3b Inactivator FITC2018-09-12 Fluorescein conjugated polyclonal goat antiserum to Human C3b Inactivator
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B176131 - Antiserum to Human Myoglobin2018-07-06
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B1761520 - Antiserum to Apolipprotein B2018-07-06

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