biokitHSV-2

GUDID 08426951056439

Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, rapid ICT, clinical

Primary Device ID	08426951056439
NIH Device Record Key	7f424a0f-e9cc-4126-bfaa-c5c7a895a1f9
Commercial Distribution Status	In Commercial Distribution
Brand Name	biokitHSV-2
Version Model Number	300028001
Company DUNS	460055742
Company Name	BIOKIT, S.A.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	08426951056439 [Primary]

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

Steralize Prior To Use	false
Device Is Sterile	false

08426950344773 - Color Mono 50 TESTS	2025-07-17 1.4 ml REAGENT 1.0 ml CONTROL + 1.0 ml CONTROL – 2 x 9 SLIDES
08426950590453 - ASO Titer Control	2025-07-17 2 x 0.5 ml titrated control
08426950590477 - RF Titer Control	2025-07-17 2 x 1 ml titrated control
08426950590569 - Rubagen 100 TESTS	2022-11-28 1 x 1.7 ml LATEX REAGENT 1 x 1.0 ml HIGH POSITIVE CONTROL 1 x 1.0 ml LOW POSITIVE CONTROL 1 x 1.0 ml NEGATIVE CONTROL 1 x 35 ml
08426950590576 - Rubajet 100 TESTS	2022-11-28 1 x 1.7 ml LATEX REAGENT 1 x 1.5 ml HIGH POSITIVE CONTROL 1 x 1.5 ml LOW POSITIVE CONTROL 1 x 15 ml DILUENT BUFFER 13 disposable
08426950590583 - Rubajet 500 TESTS	2022-11-28 5 x 1.7 ml LATEX REAGENT 2 x 1.5 ml HIGH POSITIVE CONTROL 2 x 1.5 ml LOW POSITIVE CONTROL 2 x 15 ml DILUENT BUFFER 45 disposable
08426951056439 - biokitHSV-2	2022-10-1820 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
08426951056439 - biokitHSV-2	2022-10-18 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
08426950639725 - BIO-FLASH	2022-09-16 BIO-FLASH