MarDx 40-8696P

GUDID 05391516746601

Borrelia burgdorferi EIA IgG + IgM

CLARK LABORATORIES, INC.

Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
Primary Device ID05391516746601
NIH Device Record Key0df89d4c-6e85-438a-8eaa-7a5b63b9bae4
Commercial Distribution StatusIn Commercial Distribution
Brand NameMarDx
Version Model Number40-8696P
Catalog Number40-8696P
Company DUNS623214079
Company NameCLARK LABORATORIES, INC.
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 Usefalse
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

Phone1-800-325-3424
EmailCustomerservice@trinityusa.com

Device Dimensions

Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105391516746601 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LSRReagent, Borrelia Serological Reagent

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-06
Device Publish Date2017-05-07

On-Brand Devices [MarDx]

05391516746649Borrelia burgdorferi EIA IgM
05391516746632Borrelia burgdorferi EIA IgM
05391516746618Borrelia burgdorferi EIA IgG + IgM
05391516746601Borrelia burgdorferi EIA IgG + IgM
05391516746625Borrelia burgdorferi EIA IgG

Trademark Results [MarDx]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MARDX
MARDX
75802570 2490009 Live/Registered
MarDx Diagnostics, Inc.
1999-09-17
MARDX
MARDX
75801516 2364681 Live/Registered
MarDx Diagnostics, Inc.
1999-09-17
MARDX
MARDX
73649657 1512233 Dead/Cancelled
MARDX DIAGNOSTICS, INC.
1987-03-16

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