AIX1000 Analyzer

GUDID B350004000

AIX1000 Rapid Plasma Reagin (RPR) Analyzer

GOLD STANDARD DIAGNOSTICS CORP.

Treponema pallidum reagin antibody IVD, kit, agglutination
Primary Device IDB350004000
NIH Device Record Key8dc581b9-91f9-484d-9731-e4bdc3ab8a8e
Commercial Distribution StatusIn Commercial Distribution
Brand NameAIX1000 Analyzer
Version Model Number00400
Company DUNS790524891
Company NameGOLD STANDARD DIAGNOSTICS CORP.
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 Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB350004000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GMQAntigens, Nontreponemal, All

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 Date2016-11-29

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