NovaLisa Coxiella burnetii (Q-Fever) Phase 2 IgG COX2G0600

GUDID ENTICOX2G0600

The Coxiella burnetii (Q-Fever) Phase 2 IgG ELISA is intended for the qualitative determination of IgG class antibodies against Coxiella burnetii (Q-Fever) Phase 2 in human serum or plasma (citrate, heparin).

Gold Standard Diagnostics Frankfurt GmbH

Coxiella burnetii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Primary Device IDENTICOX2G0600
NIH Device Record Key620fe44a-8f2b-43a1-86f9-03d59d771df6
Commercial Distribution StatusIn Commercial Distribution
Brand NameNovaLisa Coxiella burnetii (Q-Fever) Phase 2 IgG
Version Model NumberCOX2G0600
Catalog NumberCOX2G0600
Company DUNS330328514
Company NameGold Standard Diagnostics Frankfurt GmbH
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(888)977-4739
EmailGSD.TechSupport@us.goldstandarddiagnostics.com
Phone+1(888)977-4739
EmailGSD.TechSupport@us.goldstandarddiagnostics.com
Phone+1(888)977-4739
EmailGSD.TechSupport@us.goldstandarddiagnostics.com
Phone+1(888)977-4739
EmailGSD.TechSupport@us.goldstandarddiagnostics.com
Phone+1(888)977-4739
EmailGSD.TechSupport@us.goldstandarddiagnostics.com
Phone+1(888)977-4739
EmailGSD.TechSupport@us.goldstandarddiagnostics.com
Phone+1(888)977-4739
EmailGSD.TechSupport@us.goldstandarddiagnostics.com
Phone+1(888)977-4739
EmailGSD.TechSupport@us.goldstandarddiagnostics.com
Phone+1(888)977-4739
EmailGSD.TechSupport@us.goldstandarddiagnostics.com
Phone+1(888)977-4739
EmailGSD.TechSupport@us.goldstandarddiagnostics.com
Phone+1(888)977-4739
EmailGSD.TechSupport@us.goldstandarddiagnostics.com
Phone+1(888)977-4739
EmailGSD.TechSupport@us.goldstandarddiagnostics.com
Phone+1(888)977-4739
EmailGSD.TechSupport@us.goldstandarddiagnostics.com
Phone+1(888)977-4739
EmailGSD.TechSupport@us.goldstandarddiagnostics.com
Phone+1(888)977-4739
EmailGSD.TechSupport@us.goldstandarddiagnostics.com
Phone+1(888)977-4739
EmailGSD.TechSupport@us.goldstandarddiagnostics.com
Phone+1(888)977-4739
EmailGSD.TechSupport@us.goldstandarddiagnostics.com
Phone+1(888)977-4739
EmailGSD.TechSupport@us.goldstandarddiagnostics.com
Phone+1(888)977-4739
EmailGSD.TechSupport@us.goldstandarddiagnostics.com
Phone+1(888)977-4739
EmailGSD.TechSupport@us.goldstandarddiagnostics.com
Phone+1(888)977-4739
EmailGSD.TechSupport@us.goldstandarddiagnostics.com
Phone+1(888)977-4739
EmailGSD.TechSupport@us.goldstandarddiagnostics.com
Phone+1(888)977-4739
EmailGSD.TechSupport@us.goldstandarddiagnostics.com
Phone+1(888)977-4739
EmailGSD.TechSupport@us.goldstandarddiagnostics.com
Phone+1(888)977-4739
EmailGSD.TechSupport@us.goldstandarddiagnostics.com
Phone+1(888)977-4739
EmailGSD.TechSupport@us.goldstandarddiagnostics.com
Phone+1(888)977-4739
EmailGSD.TechSupport@us.goldstandarddiagnostics.com
Phone+1(888)977-4739
EmailGSD.TechSupport@us.goldstandarddiagnostics.com
Phone+1(888)977-4739
EmailGSD.TechSupport@us.goldstandarddiagnostics.com
Phone+1(888)977-4739
EmailGSD.TechSupport@us.goldstandarddiagnostics.com
Phone+1(888)977-4739
EmailGSD.TechSupport@us.goldstandarddiagnostics.com
Phone+1(888)977-4739
EmailGSD.TechSupport@us.goldstandarddiagnostics.com
Phone+1(888)977-4739
EmailGSD.TechSupport@us.goldstandarddiagnostics.com
Phone+1(888)977-4739
EmailGSD.TechSupport@us.goldstandarddiagnostics.com

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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCENTICOX2G0600 [Primary]

FDA Product Code

GPSAntigen, Cf, Q Fever

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-09-03
Device Publish Date2024-08-26

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ENTILEPG06600 - NovaLisa Leptospira IgG2024-09-10 The Leptospira IgG ELISA is intended for the qualitative determination of IgG class antibodies against Leptospira spp. in human
ENTIMEAG03300 - NovaLisa Measles Virus IgG2024-09-10 The Measles Virus IgG ELISA is intended for the qualitative determination of IgG class antibodies against Measles Virus in human
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