FDA.reportPublic FDA data

Diazyme

Primary DI
00817089021211
Brand
Diazyme
Company
DIAZYME LABORATORIES, INC.
Model
DZ042A-K01
Published
2016-11-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00817089021211PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817089021211008170890212118170890212110817089021211

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080507219
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
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
00817089020504DiazymeDZ042A-CAL2016-11-03
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

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
00817089020504DiazymeDIAZYME LABORATORIES, INC.KWW2016-11-03
00817089020511DiazymeDIAZYME LABORATORIES, INC.KWW2016-11-03
00817089021204DiazymeDIAZYME 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