Anti-HSV-1 (gC1) ELISA (IgG)

GUDID 04049016096726

EUROIMMUN Medizinische Labordiagnostika AG

Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Primary Device ID04049016096726
NIH Device Record Key7acdbc1f-1a8f-4d25-903a-deb37ece2c3f
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnti-HSV-1 (gC1) ELISA (IgG)
Version Model NumberEI 2531-9601-24 G
Company DUNS322209263
Company NameEUROIMMUN Medizinische Labordiagnostika AG
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104049016096726 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MXJEnzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1

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 Date2016-09-24

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