Lumipulse BRAHMS PCT Controls

GUDID 04987270234167

Procalcitonin (PCT) IVD, control

Primary Device ID	04987270234167
NIH Device Record Key	cc36f874-7329-489c-9473-63abdd77e597
Commercial Distribution Status	In Commercial Distribution
Brand Name	Lumipulse BRAHMS PCT Controls
Version Model Number	234167
Company DUNS	710873907
Company Name	FUJIREBIO 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

Device Size Text, specify	0
Device Size Text, specify	0

Handling Environment Temperature	Between 2 Degrees Celsius and 10 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 10 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 10 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *right side up with care, no vibration
Storage Environment Temperature	Between 2 Degrees Celsius and 10 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 10 Degrees Celsius

Device Issuing Agency	Device ID
GS1	04987270234167 [Primary]

NTM	Antigen, Inflammatory Response Marker, Sepsis

Steralize Prior To Use	false
Device Is Sterile	false

04987270234167	234167
04987270234945	234945