BÜHLMANN fCAL® ELISA

GUDID EBUHBEKCAL20

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

Bühlmann Laboratories AG

Calprotectin IVD, kit, enzyme immunoassay (EIA)
Primary Device IDEBUHBEKCAL20
NIH Device Record Key973a242a-951a-4b0b-8f34-0366cfb14ac0
Commercial Distribution StatusIn Commercial Distribution
Brand NameBÜHLMANN fCAL® ELISA
Version Model NumberEK-CAL2
Company DUNS481261006
Company NameBühlmann Laboratories AG
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 Usefalse
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

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
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEBUHBEKCAL20 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-14
Device Publish Date2019-11-06

On-Brand Devices [BÜHLMANN fCAL® ELISA]

EBUHBEKCAL20Quantitative ELISA assay for the determination of calprotectin (MRP8/14) in human stool specimen
EBUHBEKCAL0Quantitative ELISA assay for the determination of calprotectin (MRP8/14) in human stool specimen

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