BÜHLMANN fCAL® ELISA

GUDID EBUHBEKCAL0

Calprotectin IVD, kit, enzyme immunoassay (EIA)

Primary Device ID	EBUHBEKCAL0
NIH Device Record Key	35529fec-8c64-4ddd-9b7f-182784fdd321
Commercial Distribution Status	In Commercial Distribution
Brand Name	BÜHLMANN fCAL® ELISA
Version Model Number	EK-CAL
Company DUNS	481261006
Company Name	Bühlmann Laboratories AG
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

Device Issuing Agency	Device ID
HIBCC	EBUHBEKCAL0 [Primary]

NXO	Calprotectin, Fecal

Steralize Prior To Use	false
Device Is Sterile	false

EBUHBEKCAL20	Quantitative ELISA assay for the determination of calprotectin (MRP8/14) in human stool specimen
EBUHBEKCAL0	Quantitative ELISA assay for the determination of calprotectin (MRP8/14) in human stool specimen