THE EDGE Lactate Control Solution

GUDID 04713648766554

APEX BIOTECHNOLOGY CORP.

Lactate IVD, control Lactate IVD, control Lactate IVD, control Lactate IVD, control Lactate IVD, control Lactate IVD, control Lactate IVD, control Lactate IVD, control Lactate IVD, control Lactate IVD, control Lactate IVD, control Lactate IVD, control Lactate IVD, control Lactate IVD, control Lactate IVD, control Lactate IVD, control
Primary Device ID04713648766554
NIH Device Record Keya33c0c8c-082d-4ed5-9e0d-5c0e820cc281
Commercial Distribution StatusIn Commercial Distribution
Brand NameTHE EDGE Lactate Control Solution
Version Model NumberThe EDGE control solution
Company DUNS657608092
Company NameAPEX BIOTECHNOLOGY CORP.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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
GS104713648766554 [Primary]

FDA Product Code

KHPAcid, Lactic, Enzymatic Method

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-26
Device Publish Date2021-01-18

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