FDA.reportPublic FDA data

Extraction Kit - 12 buffer containers

Primary DI
EBUHBCALEX120
Brand
Extraction Kit - 12 buffer containers
Company
Bühlmann Laboratories AG
Model
B-CAL-EX12
Published
2020-04-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EBUHBCALEX120PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Faecal specimen extraction buffer IVDA buffered solution intended to be used for the processing and preparation of a faecal specimen for subsequent clinical testing. It is typically used for the extraction of specific target analytes present in faecal matter (e.g., calprotectin).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
481261006
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

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EBUHBEKCAL0BÜHLMANN fCAL® ELISAEK-CAL2019-11-06
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