Primary Device ID | 08426950590460 |
NIH Device Record Key | 0ccc49e6-4310-4b1b-80b3-ed6a5e9e3ccd |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | CRP Titer Control |
Version Model Number | 300021061 |
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 |
Phone | 1-800-926-3353 |
support@inovadx.com | |
Phone | 1-800-926-3353 |
support@inovadx.com | |
Phone | 1-800-926-3353 |
support@inovadx.com | |
Phone | 1-800-926-3353 |
support@inovadx.com | |
Phone | 1-800-926-3353 |
support@inovadx.com | |
Phone | 1-800-926-3353 |
support@inovadx.com |
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 Issuing Agency | Device ID |
---|---|
GS1 | 08426950590460 [Primary] |
DCK | C-Reactive Protein, Antigen, Antiserum, And Control |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2022-06-10 |
Device Publish Date | 2016-09-23 |
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 | 2022-06-102 x 1 ml titrated control |
08426950590460 - CRP Titer Control | 2022-06-10 2 x 1 ml titrated control |