Diazyme

Primary DI
00817089020412
Brand
Diazyme
Company
DIAZYME LABORATORIES, INC.
Model
DZ116B-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
JIIAtomic Absorption, Lithium

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JIIAtomic Absorption, LithiumClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082001000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082001000DIAZYME LIQUID STABLE ENZYMATIC LITHIUM ASSAY, MODEL DZ116BDiazyme Laboratories2008-12-05JII

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817089020412PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817089020412008170890204128170890204120817089020412

GMDN Terms#

Term, Definition table
TermDefinition
Lithium therapeutic drug monitoring IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement and therapeutic monitoring of the central nervous system drug lithium 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
00817089020429DiazymeDIAZYME LABORATORIES, INC.JII2016-11-03
00817089021259DiazymeDIAZYME LABORATORIES, INC.JII2016-11-03