CRP Titer Control

GUDID 08426950590460

2 x 1 ml titrated control

BIOKIT, S.A.

C-reactive protein (CRP) IVD, control
Primary Device ID08426950590460
NIH Device Record Key0ccc49e6-4310-4b1b-80b3-ed6a5e9e3ccd
Commercial Distribution StatusIn Commercial Distribution
Brand NameCRP Titer Control
Version Model Number300021061
Company DUNS460055742
Company NameBIOKIT, S.A.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-926-3353
Emailsupport@inovadx.com
Phone1-800-926-3353
Emailsupport@inovadx.com
Phone1-800-926-3353
Emailsupport@inovadx.com
Phone1-800-926-3353
Emailsupport@inovadx.com
Phone1-800-926-3353
Emailsupport@inovadx.com
Phone1-800-926-3353
Emailsupport@inovadx.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108426950590460 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DCKC-Reactive Protein, Antigen, Antiserum, And Control

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-06-10
Device Publish Date2016-09-23

Devices Manufactured by BIOKIT, S.A.

08426950590569 - Rubagen 100 TESTS2022-11-28 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 TESTS2022-11-28 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 TESTS2022-11-28 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-22022-10-18 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-FLASH2022-09-16 BIO-FLASH
08426950589365 - Rheumajet CRP 100 TESTS2022-06-10 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 Control2022-06-102 x 1 ml titrated control
08426950590460 - CRP Titer Control2022-06-10 2 x 1 ml titrated control

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