FDA.reportPublic FDA data

Diazyme

Primary DI
00817089021594
Brand
Diazyme
Company
DIAZYME LABORATORIES, INC.
Model
DZ168C-KY1
Published
2020-07-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LCPAssay, Glycosylated Hemoglobin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LCPAssay, Glycosylated HemoglobinHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160762000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160762000Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control SetDiazyme Laboratories2016-11-21LCP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817089021594PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817089021594008170890215948170890215940817089021594

GMDN Terms#

Term, Definition table
TermDefinition
Glycated haemoglobin (HbA1c) IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of glycated haemoglobin (HbA1c), also known as glycosylated haemoglobin 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
00380740208622ARCHITECTAbbott GmbHLCP2026-05-15
00380740208639AlinityAbbott GmbHLCP2026-05-15
00860004423409QvinQurasense, Inc.LCP2026-05-08
00860004423492QvinQurasense, Inc.LCP2026-05-08
04562185405262GR01 HbA1c Elution Buffer No. 1TOSOH CORPORATIONLCP2026-01-05
04562185405279GR01 HbA1c Elution Buffer No. 2TOSOH CORPORATIONLCP2026-01-05
04562185405286GR01 HbA1c Elution Buffer No. 3TOSOH CORPORATIONLCP2026-01-05
04562185400571HbA1c Diluting SolutionTOSOH CORPORATIONLCP2026-01-05
04562185404920Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01TOSOH CORPORATIONLCP2026-01-05
0456218540493790 Sample Loader TOSOH CORPORATIONLCP2026-01-05
04562185404944290 Sample LoaderTOSOH CORPORATIONLCP2026-01-05
04562185405255TSKgel GR01 HbA1c ColumnTOSOH CORPORATIONLCP2026-01-05
14562185405269GR01 HbA1c Elution Buffer No. 1TOSOH CORPORATIONLCP2026-01-05
14562185405276GR01 HbA1c Elution Buffer No. 2TOSOH CORPORATIONLCP2026-01-05
14562185405283GR01 HbA1c Elution Buffer No. 3TOSOH CORPORATIONLCP2026-01-05
04562185406207Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 LATOSOH CORPORATIONLCP2026-01-05
04713106028187URIGHT Hemoglobin A1c AnalyzerTAIDOC TECHNOLOGY CORPORATIONLCP2025-03-26
05391516749893Trinity BiotechPRIMUS CORPORATIONLCP2024-04-12
05391516749909Trinity BiotechPRIMUS CORPORATIONLCP2024-04-12
05391516749916Trinity BiotechPRIMUS CORPORATIONLCP2024-04-12
05391516749923Trinity BiotechPRIMUS CORPORATIONLCP2024-04-12
05391516749930Trinity Biotech PRIMUS CORPORATIONLCP2024-04-12
10304040178437Henry ScheinHENRY SCHEIN, INC.LCP2024-01-12
00304040178430Henry ScheinHENRY SCHEIN, INC.LCP2024-01-12
10673486001792Teco Diagnostics Hemoglobin A1c (HbA1c) Reagent SetTECO DIAGNOSTICSLCP2023-11-15
10673486001808Teco Diagnostics Hemoglobin A1c Set for TC Matrix SystemsTECO DIAGNOSTICSLCP2023-11-10
00381933080018A1CNow Self Check, 8ct.POLYMER TECHNOLOGY SYSTEMS, INC.LCP2023-10-25
10381933080015A1CNow Self Check, 8ct.POLYMER TECHNOLOGY SYSTEMS, INC.LCP2023-10-25
03661540304286Direct A1c Control KitELITECHGROUP INC.LCP2023-10-01
03661540304293Direct A1c Calibrator KitELITECHGROUP INC.LCP2023-10-01