AccessGUDID - DEVICE: Pointe Scientific, Inc. HSV-1 & 2 IgG (00811727015211)

GUDID

Device Identifier (DI) Information

Brand Name: Pointe Scientific, Inc. HSV-1 & 2 IgG
Version or Model: T8007-96
Commercial Distribution Status: In Commercial Distribution
Catalog Number: T8007-96
Company Name: POINTE SCIENTIFIC, INC.

Primary DI Number: 00811727015211
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 045623154 *Terms of Use

Device Description: Pointe Scientific, Inc. HSV-1 & 2 IgG Reagent is for the qualitative, and semi-quantitative detection of human IgG antibodies to type 1 and type 2 herpes simplex virus (HSV) in human serum by enzyme immunoassay. To aid in the evaluation of the patient's immunological history with HSV, including women of childbearing age. These reagents have not received FDA clearance for use in testing blood or plasma donors. 96 tests.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
49541	Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to herpes simplex virus 1 and/or herpes simplex virus 2 (HSV1 & 2) in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LGC	Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K963282	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 62535568-3a61-45b3-8d26-d9161c140a6b
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 31, 2016