AccessGUDID - DEVICE: biokitHSV-2 (08426951056439)

GUDID

Device Identifier (DI) Information

Brand Name: biokitHSV-2
Version or Model: 300028001
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: BIOKIT, S.A.

Primary DI Number: 08426951056439
Issuing Agency: GS1
Commercial Distribution End Date: November 06, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 460055742 *Terms of Use

Device Description: 20 Test Devices 20 x 0,7 ml Sample Diluent 20 x 0,5 ml Developing Reagent 20 x Empty Vials 1 20 x Pre-filter tips 20 x Capillary tubes 20 x Lancets 20 x Swabs 20 x Tube racks

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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
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?
63294	Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, rapid ICT, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of immunoglobulin G (IgG) antibodies to herpes simplex virus 2 (HSV2) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.	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 [?]
Premarket Submission Number Not Available/Not Released

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7f424a0f-e9cc-4126-bfaa-c5c7a895a1f9
Public Version Date: April 08, 2025
Public Version Number: 2
DI Record Publish Date: October 10, 2022