BÜHLMANN fCAL® turbo Reagent Kit

GUDID EBUHBKPELARSET0

Bühlmann Laboratories AG

Pancreatic elastase (PE) IVD, reagent
Primary Device IDEBUHBKPELARSET0
NIH Device Record Key225528f2-54f3-4fd0-ba7e-ac6a247921da
Commercial Distribution StatusIn Commercial Distribution
Brand NameBÜHLMANN fCAL® turbo Reagent Kit
Version Model NumberB-KCAL-RSET
Company DUNS481261006
Company NameBühlmann Laboratories AG
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
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
HIBCCEBUHBKPELARSET0 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-30
Device Publish Date2020-06-22

On-Brand Devices [BÜHLMANN fCAL® turbo Reagent Kit]

EBUHBKCALRSET0Reagent kit for quantitative PETIA assay for the determination of calprotectin (MRP8/14) in huma
EBUHBKPELARSET0B-KCAL-RSET
EBUHBKCALRSETUS0B-KCAL-RSET-US

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