POINTE SCIENTIFIC CRP-High Sensitivity C7568-40

GUDID 00811727011022

C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry

Primary Device ID	00811727011022
NIH Device Record Key	41ac1206-fa73-46cf-a71e-a0b47524c82e
Commercial Distribution Status	In Commercial Distribution
Brand Name	POINTE SCIENTIFIC CRP-High Sensitivity
Version Model Number	C7568-40
Catalog Number	C7568-40
Company DUNS	045623154
Company Name	POINTE SCIENTIFIC, INC.
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	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

Device Issuing Agency	Device ID
GS1	00811727011022 [Primary]

DCK	C-Reactive Protein, Antigen, Antiserum, And Control

Steralize Prior To Use	false
Device Is Sterile	false

00811727011039	For the quantitative determination of C-reactive protein in serum or plasma by latex particle en
00811727011022	For the quantitative determination of C-reactive protein in serum or plasma by latex particle en