Catalog Number

NC-830096-AG

Brand Name

ASI HSV IgG EIA Test

Version/Model Number

NC-830096-AG

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K963282

Product Code

LGC

Product Code Name

Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific

Public Device Record Key

77061651-59fb-460d-8f29-fda7b1dc5d43

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

July 08, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-