FDA.reportPublic FDA data

Diazyme

Primary DI
00817089020504
Brand
Diazyme
Company
DIAZYME LABORATORIES, INC.
Model
DZ042A-CAL
Published
2016-11-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K051714000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051714000TOTAL BILE ACIDS ASSAY, MODEL DZ042ADiazyme Laboratories2005-12-07KWW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817089020504PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817089020504008170890205048170890205040817089020504

GMDN Terms#

Term, Definition table
TermDefinition
Total bile acid IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of total bile acids in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080507219
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817089022690DiazymeDZ558A-KY12020-07-29
00817089020900Diazyme Procalcitonin AssayDZ558A-K2017-09-01
00817089022478DiazymeDZ248A-CON2026-01-21
00817089023048DiazymeDZ122A-KY12026-01-21
00817089023222Diazyme100148B-CAL2026-01-21
00817089023239Diazyme100148B-CON2026-01-21
00817089021358DiazymeDZ168C-CAL2020-07-21
00817089021365DiazymeDZ168C-CON2020-07-21
00817089021464DiazymeDZ568A-CA52020-07-21
00817089020047DiazymeDZ122A-CAL2016-11-03
00817089020054DiazymeDZ122A-CON2016-11-03
00817089020511DiazymeDZ042A-CON2016-11-03
00817089020535DiazymeDZ179A-CAL2016-11-03
00817089020542DiazymeDZ179A-CON2016-11-03
00817089020627DiazymeDZ147A-CAL2016-11-03
00817089020634DiazymeDZ147A-CON2016-11-03
00817089020689DiazymeDZ768A-CAL2016-11-03
00817089020696DiazymeDZ768A-CON2016-11-03
00817089020863DiazymeDZ141A-CAL2016-11-03
00817089022539DiazymeDZ152A-CON2023-11-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03701037317037FX V135 Shoulder ProsthesisFX SOLUTIONSKWW2024-01-23
00853618007011Catachem DiscretPak™CATACHEM, INC.KWW2016-11-11
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