CALEX Cap

GUDID EBUH089109870010

Bühlmann Laboratories AG

Faecal specimen container IVD, transport buffer/medium
Primary Device IDEBUH089109870010
NIH Device Record Keya314c5dc-5c12-4fcb-afd0-c4af8598255b
Commercial Distribution StatusIn Commercial Distribution
Brand NameCALEX Cap
Version Model Number08910987001
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
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
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
HIBCCEBUH089109870010 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-07-22
Device Publish Date2020-05-27

Devices Manufactured by Bühlmann Laboratories AG

EBUHBCCRLYR20 - CAST® Lysing Reagent Basophil2025-03-12 CAST® Lysing Reagent Basophil (B-CCR-LYR20) is a red cell lysing reagent designed for selective lysis of erythrocytes in basoph
EBUHBCCRSR20 - CAST® Staining Reagent Basophil2025-03-12 CAST® Staining Reagent Basophil (B-CCR-SR20) is an analyte-specific reagent (ASR) containing fluorescently labeled anti-CCR3 an
EBUHBCCRSTB5 - CAST® Stimulation Buffer Basophil2025-03-12 CAST® Stimulation Buffer Basophil (B-CCR-STB5) is a blood cell diluent, optimized to support basophil activation in basophil ac
EBUHBCCRSTCON10 - CAST® Stimulation Control Basophil2025-03-12 CAST® Stimulation Control Basophil (B-CCR-STCON10) is an analyte-specific reagent (ASR) containing a monoclonal anti-FceRI anti
EBUHBCCRWB10 - CAST® Wash Buffer Basophil2025-03-12 CAST® Wash Buffer Basophil (B-CCR-WB10) is a formalin-saline solution used to wash, fixate and reconstitute basophils in basoph
EBUHBCALSAMPLER250 - Simple Sampler Stool Collection Set2023-07-04
EBUHBKCALRSETUS0 - BÜHLMANN fCAL® turbo Reagent Kit2023-05-10
04260714340007 - fCAL turbo2022-06-21

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.