AtheNA Multi-Lyte® TPO/Tg IgG Plus Test System A51101

GUDID 00845533000109

The ZEUS AtheNA Multi-Lyte® TPO/Tg Plus Test System is intended for the quantitative detection of IgG class antibody to 2 separate Thyroid Antigens; Thyroid Peroxidase (TPO) and Thyroglobulin (Tg), in human serum. The test system is intended to be used as an aid in the diagnosis of various autoimmune thyroid diseases. This test is for In Vitro diagnostic use only.

ZEUS SCIENTIFIC, INC.

Thyroglobulin/Thyroid peroxidase antibody (anti-TPO/Microsomal antibody) IVD, kit, fluorescent immunoassay Multiple thyroid antibody IVD, kit, fluorescent immunoassay Multiple thyroid antibody IVD, kit, fluorescent immunoassay Multiple thyroid antibody IVD, kit, fluorescent immunoassay Multiple thyroid antibody IVD, kit, fluorescent immunoassay Multiple thyroid antibody IVD, kit, fluorescent immunoassay Multiple thyroid antibody IVD, kit, fluorescent immunoassay Multiple thyroid antibody IVD, kit, fluorescent immunoassay Multiple thyroid antibody IVD, kit, fluorescent immunoassay Multiple thyroid antibody IVD, kit, fluorescent immunoassay Multiple thyroid antibody IVD, kit, fluorescent immunoassay Multiple thyroid antibody IVD, kit, fluorescent immunoassay Multiple thyroid antibody IVD, kit, fluorescent immunoassay Multiple thyroid antibody IVD, kit, fluorescent immunoassay Multiple thyroid antibody IVD, kit, fluorescent immunoassay Multiple thyroid antibody IVD, kit, fluorescent immunoassay Multiple thyroid antibody IVD, kit, fluorescent immunoassay Multiple thyroid autoantibody IVD, kit, fluorescent immunoassay Multiple thyroid autoantibody IVD, kit, fluorescent immunoassay Multiple thyroid autoantibody IVD, kit, fluorescent immunoassay Multiple thyroid autoantibody IVD, kit, fluorescent immunoassay Multiple thyroid autoantibody IVD, kit, fluorescent immunoassay Multiple thyroid autoantibody IVD, kit, fluorescent immunoassay Multiple thyroid autoantibody IVD, kit, fluorescent immunoassay Multiple thyroid antibody IVD, kit, fluorescent immunoassay Multiple thyroid antibody IVD, kit, fluorescent immunoassay Multiple thyroid antibody IVD, kit, fluorescent immunoassay Multiple thyroid antibody IVD, kit, fluorescent immunoassay Multiple thyroid antibody IVD, kit, fluorescent immunoassay Multiple thyroid antibody IVD, kit, fluorescent immunoassay Multiple thyroid antibody IVD, kit, fluorescent immunoassay Multiple thyroid antibody IVD, kit, fluorescent immunoassay Multiple thyroid antibody IVD, kit, fluorescent immunoassay Multiple thyroid antibody IVD, kit, fluorescent immunoassay Multiple thyroid antibody IVD, kit, fluorescent immunoassay Multiple thyroid antibody IVD, kit, fluorescent immunoassay Multiple thyroid antibody IVD, kit, fluorescent immunoassay Multiple thyroid antibody IVD, kit, fluorescent immunoassay Multiple thyroid antibody IVD, kit, fluorescent immunoassay Multiple thyroid antibody IVD, kit, fluorescent immunoassay Multiple thyroid antibody IVD, kit, fluorescent immunoassay
Primary Device ID00845533000109
NIH Device Record Key0bf66e7d-2ff4-4a46-a536-e83827bebf80
Commercial Distribution StatusIn Commercial Distribution
Brand NameAtheNA Multi-Lyte® TPO/Tg IgG Plus Test System
Version Model NumberA51101
Catalog NumberA51101
Company DUNS080953946
Company NameZEUS SCIENTIFIC, 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 Usetrue
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100845533000109 [Primary]

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 Date2016-09-24

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Trademark Results [AtheNA Multi-Lyte]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ATHENA MULTI-LYTE
ATHENA MULTI-LYTE
76665931 3284216 Dead/Cancelled
Zeus Scientific, Inc.
2006-09-11
ATHENA MULTI-LYTE
ATHENA MULTI-LYTE
76665930 3267101 Live/Registered
Zeus Scientific, Inc.
2006-09-11
ATHENA MULTI-LYTE
ATHENA MULTI-LYTE
76091059 2813370 Dead/Cancelled
Zeus Scientific, Inc.
2000-07-18

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