R. Prowazekii 12 well; 10 pk I-RPR01X

GUDID 00813545026103

SCIMEDX CORPORATION

Multiple Rickettsia species (typhus group) antigen IVD, kit, agglutination
Primary Device ID00813545026103
NIH Device Record Keya4d4884d-da5c-4801-aa65-0096778661a3
Commercial Distribution StatusIn Commercial Distribution
Brand NameR. Prowazekii 12 well; 10 pk
Version Model NumberI-RPR01X
Catalog NumberI-RPR01X
Company DUNS155424708
Company NameSCIMEDX CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone18002215598
Emailservice@scimedx.com
Phone18002215598
Emailservice@scimedx.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100813545026103 [Primary]

FDA Product Code

LSQReagent, Rickettsia Serological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-21

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00813545026578 - MeDiCa2020-12-09 Rat Liver 8 Well Slide (each)
00813545026585 - MeDiCa2020-12-09 Crithidia luciliae 4 Well Slide (each)
00813545026592 - MeDiCa2020-12-09 Crithidia luciliae 8 Well Slide (each)

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