Platelet PGDprime Negative Control

GUDID 10850046056052

Lipoteichoic acid (LTA)/lipopolysaccharide (LPS) IVD, kit, rapid ICT, clinical

Primary Device ID	10850046056052
NIH Device Record Key	d9f8d12a-e6c4-4a7c-989a-8a80311c2de7
Commercial Distribution Status	In Commercial Distribution
Brand Name	Platelet PGDprime Negative Control
Version Model Number	P01113
Company DUNS	102312712
Company Name	Verax Biomedical Incorporated
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
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

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
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 Issuing Agency	Device ID
GS1	10850046056052 [Primary]

JJY	Multi-Analyte Controls, All Kinds (Assayed)

Steralize Prior To Use	false
Device Is Sterile	false

10850046056021 - Platelet PGDprime Reagent 1B	2023-04-27 Platelet PGDprime Reagent 1B required for processing platelet sample prior to testing with the Platelet PGDprime Test Device.
10850046056045 - Platelet PGDprime Positive Control	2023-04-27 Platelet PGDprime Positive Control for quality control testing of the Platelet PGDprime Test System.
10850046056250 - Platelet PGDprime Sample Pipettes	2023-04-27 Platelet PGDprime Sample Pipettes for adding the platelet sample to the processing tube.
10850046056243 - Platelet PGDprime Transfer Pipettes	2023-04-27 Platelet PGDprime Transfer Pipettes required to move the processed platelet sample to the Platelet PGDprime Test Device.
10850046056236 - Platelet PGDprime Processing Tubes	2023-04-27 Platelet PGDprime Processing Tubes are required for processing the platelet sample prior to testing with the Platelet PGDprime T
10850046056113 - Platelet PGDprime Test, 20 devices plus disposables	2023-04-27 Kit includes 20 Platelet PGDprime Test devices plus sample pipettes, transfer pipettes and sample processing tubes required to r
10850046056120 - Platelet PGDprime Sample Pipettes, Processing Tubes and Transfer Pipettes	2023-04-27 Platelet PGDprime Test System required disposable sample pipettes, processing tubes and transfer pipettes. 100 test kit
10850046056137 - Platelet PGDprime Reagents, 100 Test	2023-04-27 Platelet PGDprime Test Reagents required for processing the sample prior to testing with the Platelet PGDprime Test Device. 100