HIV-1/2 Antibody Test Controls

GUDID 10628451188213

HIV-1/2 Antibody Test Controls (Test Controls) are external quality control agents intended for use only with Reveal G4. These Test Controls should be used in conjunction with Good Laboratory Practices in laboratories that have established an adequate quality assurance program, including planned systematic activities to provide adequate confidence that requirements for quality will be met.

MedMira Laboratories Inc

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Primary Device ID10628451188213
NIH Device Record Key4c2f4677-6270-4c7e-93c3-ca688999cca4
Commercial Distribution StatusIn Commercial Distribution
Brand NameHIV-1/2 Antibody Test Controls
Version Model Number815311007545
Company DUNS243757049
Company NameMedMira 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone902-450-1588
Emailjennifer.maclellan@medmira.com
Phone902-450-1588
Emailjennifer.maclellan@medmira.com
Phone902-450-1588
Emailjennifer.maclellan@medmira.com
Phone902-450-1588
Emailjennifer.maclellan@medmira.com
Phone902-450-1588
Emailjennifer.maclellan@medmira.com
Phone902-450-1588
Emailjennifer.maclellan@medmira.com
Phone902-450-1588
Emailjennifer.maclellan@medmira.com
Phone902-450-1588
Emailjennifer.maclellan@medmira.com
Phone902-450-1588
Emailjennifer.maclellan@medmira.com
Phone902-450-1588
Emailjennifer.maclellan@medmira.com
Phone902-450-1588
Emailjennifer.maclellan@medmira.com
Phone902-450-1588
Emailjennifer.maclellan@medmira.com
Phone902-450-1588
Emailjennifer.maclellan@medmira.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110628451188213 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MZFTest, Hiv Detection

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-19
Device Publish Date2024-04-11

On-Brand Devices [HIV-1/2 Antibody Test Controls]

10628451188268HIV-1/2 Antibody Test Controls (Test Controls) are external quality control agents intended for
10628451188251HIV-1/2 Antibody Test Controls (Test Controls) are external quality control agents intended for
10628451188213HIV-1/2 Antibody Test Controls (Test Controls) are external quality control agents intended for
00628451188209HIV-1/2 Antibody Test Controls (Test Controls) are external quality control agents intended for
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