FDA.reportPublic FDA data

Catachem DiscretPak™

Primary DI
00853618007011
Brand
Catachem DiscretPak™
Company
CATACHEM, INC.
Model
C402-0C
Catalog number
C402-0C
Device description
Bile Acids (Colormetric) Kit C
Published
2016-11-11
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWWRadioimmunoassay, Cholyglycine, Bile Acids

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWWRadioimmunoassay, Cholyglycine, Bile AcidsClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K062503000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062503000CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KITCatachem, Inc.2007-01-19KWW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853618007011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853618007011008536180070118536180070110853618007011

GMDN Terms#

Term, Definition table
TermDefinition
Total bile acid IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of total bile acids in a clinical specimen, using an enzyme spectrophotometry method.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
203-262-0330info@catacheminc.com

Regulatory Flags#

DUNS number
109130625
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03701037317037FX V135 Shoulder ProsthesisFX SOLUTIONSKWW2024-01-23
00817089020504DiazymeDIAZYME LABORATORIES, INC.KWW2016-11-03
00817089020511DiazymeDIAZYME LABORATORIES, INC.KWW2016-11-03
00817089021204DiazymeDIAZYME LABORATORIES, INC.KWW2016-11-03
00817089021211DiazymeDIAZYME LABORATORIES, INC.KWW2016-11-03
00817830022290Conjugated Bile Acids 125I RIA KitMP BIOMEDICALS, LLCKWW2016-10-20
05391516741873Trinity BiotechTRINITY BIOTECH PUBLIC LIMITED COMPANYKWW2016-09-23
05391516741880Trinity BiotechTRINITY BIOTECH PUBLIC LIMITED COMPANYKWW2016-09-23
05391516741903Trinity BiotechTRINITY BIOTECH PUBLIC LIMITED COMPANYKWW2016-09-23
05391516741910Trinity BiotechTRINITY BIOTECH PUBLIC LIMITED COMPANYKWW2016-09-23
05391516741927Trinity BiotechTRINITY BIOTECH PUBLIC LIMITED COMPANYKWW2016-09-23