Catachem DiscretPak™ C402-0C

GUDID 00853618007011

Bile Acids (Colormetric) Kit C

CATACHEM, INC.

Total bile acid IVD, kit, enzyme spectrophotometry
Primary Device ID00853618007011
NIH Device Record Keyf457ef9d-307d-417f-9b35-9cbc259de5cd
Commercial Distribution Discontinuation2018-11-30
Commercial Distribution StatusNot in Commercial Distribution
Brand NameCatachem DiscretPak™
Version Model NumberC402-0C
Catalog NumberC402-0C
Company DUNS109130625
Company NameCATACHEM, INC.
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone203-262-0330
Emailinfo@catacheminc.com
Phone203-262-0330
Emailinfo@catacheminc.com
Phone203-262-0330
Emailinfo@catacheminc.com
Phone203-262-0330
Emailinfo@catacheminc.com
Phone203-262-0330
Emailinfo@catacheminc.com
Phone203-262-0330
Emailinfo@catacheminc.com
Phone203-262-0330
Emailinfo@catacheminc.com
Phone203-262-0330
Emailinfo@catacheminc.com
Phone203-262-0330
Emailinfo@catacheminc.com
Phone203-262-0330
Emailinfo@catacheminc.com
Phone203-262-0330
Emailinfo@catacheminc.com
Phone203-262-0330
Emailinfo@catacheminc.com
Phone203-262-0330
Emailinfo@catacheminc.com
Phone203-262-0330
Emailinfo@catacheminc.com
Phone203-262-0330
Emailinfo@catacheminc.com
Phone203-262-0330
Emailinfo@catacheminc.com

Device Dimensions

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Device Size Text, specify0

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
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100853618007011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWWRadioimmunoassay, Cholyglycine, Bile Acids

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-11-30
Device Publish Date2016-11-11

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