L.pneu 1-6 IFA Poly(HT)60 Test 7160

GUDID 00813545020927

SCIMEDX CORPORATION

Legionella pneumophila total antibody IVD, kit, fluorescent immunoassay
Primary Device ID00813545020927
NIH Device Record Key32fd29f4-7a58-40b0-ae04-3f3342bbd004
Commercial Distribution StatusIn Commercial Distribution
Brand NameL.pneu 1-6 IFA Poly(HT)60 Test
Version Model Number7160
Catalog Number7160
Company DUNS155424708
Company NameSCIMEDX CORPORATION
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 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
GS100813545020927 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LHLReagents, Antibody, Legionella, Direct & Indirect Fluorescent

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 Date2016-09-16

Devices Manufactured by SCIMEDX CORPORATION

00813545023843 - ProSorb-G 2 ml 50 Test2023-06-21 IgG Removal Reagent
00813545029029 - GBM IgG Test System2023-06-21
00813545029036 - MBO IgG Test System2023-06-21
00813545029043 - PR3 IgG Test System2023-06-21
00813545026561 - MeDiCa2020-12-09 Rat Liver 4 Well Slide (each)
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)

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