FDA.reportPublic FDA data

Diazyme

Primary DI
00817089022539
Brand
Diazyme
Company
DIAZYME LABORATORIES, INC.
Model
DZ152A-CON
Published
2023-11-29
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
NOZAssay, 1,5-Anhydroglucitol (15ag)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NOZAssay, 1,5-Anhydroglucitol (15ag)Hematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180209000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180209000Diazyme 1,5-AG AssayDiazyme Laboratories, Inc.2018-10-04NOZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817089022539PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817089022539008170890225398170890225390817089022539

GMDN Terms#

Term, Definition table
TermDefinition
1,5-Anhydroglucitol IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of 1,5-anhydroglucitol 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

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
00817089022584DiazymeDIAZYME LABORATORIES, INC.NOZ2023-11-29
00817089022744DiazymeDIAZYME LABORATORIES, INC.NOZ2023-11-29
04987170775562GLYCOMARKNIPPON KAYAKU CO., LTD.NOZ2016-09-24