Rubagen 100 TESTS

GUDID 08426950590569

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 DILUENT BUFFER 8 disposable slides 120 plastic stirrers

BIOKIT, S.A.

Rubella virus total antibody IVD, kit, rapid agglutination, clinical

• Primary Device ID: 08426950590569
• NIH Device Record Key: 42a54890-d4c2-4a08-b181-626dabfa4b2a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rubagen 100 TESTS
• Version Model Number: 300024001
• 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: true
• 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

Customer Support Contacts

• Phone: 1-800-926-3353
• Email: support@inovadx.com
• Phone: 1-800-926-3353
• Email: support@inovadx.com
• Phone: 1-800-926-3353
• Email: support@inovadx.com
• Phone: 1-800-926-3353
• Email: support@inovadx.com
• Phone: 1-800-926-3353
• Email: support@inovadx.com
• Phone: 1-800-926-3353
• Email: support@inovadx.com
• Phone: 1-800-926-3353
• Email: support@inovadx.com
• Phone: 1-800-926-3353
• Email: support@inovadx.com
• Phone: 1-800-926-3353
• Email: support@inovadx.com
• Phone: 1-800-926-3353
• Email: support@inovadx.com
• Phone: 1-800-926-3353
• Email: support@inovadx.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08426950590569 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K896433

FDA Product Code

• LQN: Latex Agglutination Assay, Rubella

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-11-28
• Device Publish Date: 2016-09-23

Devices Manufactured by BIOKIT, S.A.

• 08426950590569 - Rubagen 100 TESTS: 2022-11-281 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 DILUENT BUFFER 8 disposable slides 120 plastic stirrers
• 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: 2022-10-18 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
• 08426950589365 - Rheumajet CRP 100 TESTS: 2022-06-10 2 x 2.5 ml REAGENT 1 x 1.5 ml CONTROL + 1 x 1.5 ml CONTROL – 2 x 9 SLIDES
• 08426950590460 - CRP Titer Control: 2022-06-10 2 x 1 ml titrated control