Catalog Number

-

Brand Name

HSV-1 AND HSV-2 Differentiation Immunoblot IgG Antigen Strips

Version/Model Number

IB0901

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

K000238

Product Code

LGC

Product Code Name

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

Public Device Record Key

39b95748-0479-4d9c-a661-d2c07558b5aa

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 22, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-