Antiserum to Apolipprotein B 152002

GUDID B1761520

KENT LABORATORIES INC

Apolipoprotein B (Apo B) IVD, reagent
Primary Device IDB1761520
NIH Device Record Key3ac8d9dc-458a-4c4d-9bcc-9362c46837e1
Commercial Distribution StatusIn Commercial Distribution
Brand NameAntiserum to Apolipprotein B
Version Model Number1
Catalog Number152002
Company DUNS093642254
Company NameKENT LABORATORIES INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB1761520 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MSJApolipoproteins

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

Devices Manufactured by KENT LABORATORIES INC

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B1761082 - Anti Human Properdin FITC2018-09-12 Fluorescein conjugated polyclonal goat antiserum to Human Complement Properdin
B1761210 - Antiserum to Human C-3b Inactivator (factor I)2018-09-12 Goat antiserum to Human C-3b Inactivator (factor I)
B1761212 - Anti Human C3b Inactivator FITC2018-09-12 Fluorescein conjugated polyclonal goat antiserum to Human C3b Inactivator
B1761230 - Antiserum to Human Alpha 1 Acid Glycoprotein2018-07-06 Goat antiserum to Human Alpha 1 Acid Glycoprotein
B176131 - Antiserum to Human Myoglobin2018-07-06
B1761500 - Antiserum to Apolipoprotein A-12018-07-06
B1761520 - Antiserum to Apolipprotein B2018-07-06
B1761520 - Antiserum to Apolipprotein B2018-07-06

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