Antiserum to Apolipprotein B 152002

GUDID B1761520

KENT LABORATORIES INC

Apolipoprotein B (Apo B) IVD, reagent 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

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B1761520 - Antiserum to Apolipprotein B2018-07-06

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