FDA.reportPublic FDA data

Simple Sampler Stool Collection Set

Primary DI
EBUHBCALSAMPLER250
Brand
Simple Sampler Stool Collection Set
Company
Bühlmann Laboratories AG
Model
B-CAL-SAMPLER25
Published
2023-06-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EBUHBCALSAMPLER250PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Faecal specimen collection kit IVD, home-useA collection of devices and materials intended to be used by a layperson in the home to self-collect a faecal (stool) sample for subsequent in vitro diagnostic testing or screening purposes (e.g., occult blood, cytology) in a clinical laboratory. The kit may consist of a specimen container(s) with or without an additive/medium (e.g., cell or nucleic acid preservative solution, Carey-Blair transport medium), collection assistive device(s) (e.g., blush, spatula), gloves, labels, and/or a return packing/envelope for submission/mailing to the clinical laboratory. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

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EBUHBKCALRSET0BÜHLMANN fCAL® turbo Reagent KitB-KCAL-RSET2019-11-01
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