SAS RPR Kit

GUDID 00780311000349

SA SCIENTIFIC, LTD.

Treponema pallidum reagin antibody IVD, kit, agglutination
Primary Device ID00780311000349
NIH Device Record Keyca955485-7691-4b10-b8e7-7698df478ae2
Commercial Distribution StatusIn Commercial Distribution
Brand NameSAS RPR Kit
Version Model Number084500
Company DUNS122092117
Company NameSA SCIENTIFIC, LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
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
GS100780311000349 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-12-03
Device Publish Date2018-11-02

On-Brand Devices [SAS RPR Kit]

00780311000349084500
00780311000332084100
00780311000325Syphilis screening test.

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.