LIAISON Lyme Total Antibody Plus

GUDID 08056771602709

Diasorin Inc.

Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, chemiluminescent immunoassay
Primary Device ID08056771602709
NIH Device Record Keydefc47f6-8c51-4afd-887f-cd43ecc6b3ef
Commercial Distribution StatusIn Commercial Distribution
Brand NameLIAISON Lyme Total Antibody Plus
Version Model Number318330
Company DUNS033429783
Company NameDiasorin 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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone651-439-9710
Email[email protected]

Device Identifiers

Device Issuing AgencyDevice ID
GS108056771602709 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-11
Device Publish Date2020-02-03

Devices Manufactured by Diasorin Inc.

08056771602716 - LIAISON Lyme Total Antibody Plus Control set2020-02-11
08056771602709 - LIAISON Lyme Total Antibody Plus2020-02-11
08056771602709 - LIAISON Lyme Total Antibody Plus2020-02-11
08056771600460 - LIAISON® N-TACT® PTH Gen II Calibration Verifiers2019-12-23
08056771600453 - LIAISON® N-TACT® PTH Gen II Specimen Diluent2019-12-23
08056771600446 - LIAISON® N-TACT® PTH Gen II Control Set2019-12-23
08056771600439 - LIAISON® N-TACT® PTH Gen II2019-12-23
08056771602648 - LIAISON® XL Zika Capture IgM II Control Set2019-12-12
08056771602624 - LIAISON® XL Zika Capture IgM II2019-12-12

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