FDA.reportPublic FDA data

Diazyme

Primary DI
00817089020696
Brand
Diazyme
Company
DIAZYME LABORATORIES, INC.
Model
DZ768A-CON
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
GILPlasma, Fibrinogen Control
GISTest, Fibrinogen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GILPlasma, Fibrinogen ControlHematology2
GISTest, FibrinogenHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143470000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143470000Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control SetDiazyme Laboratories2016-01-31GIS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817089020696PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817089020696008170890206968170890206960817089020696

GMDN Terms#

Term, Definition table
TermDefinition
Fibrinogen assay (factor I) IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of fibrinogen (factor I) 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
00817089020863DiazymeDZ141A-CAL2016-11-03
00817089022539DiazymeDZ152A-CON2023-11-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00859110005128Validate Lgc Clinical Diagnostics, Inc.GIL2018-01-18
00859110005135Validate Lgc Clinical Diagnostics, Inc.GIL2018-01-18
00859110005142Validate Lgc Clinical Diagnostics, Inc.GIL2018-01-18
00816426021075K-ASSAY® Fibrinogen ReagentKAMIYA BIOMEDICAL COMPANY, LLCGIS2017-01-13
00816426021082K-ASSAY® Fibrinogen CalibratorKAMIYA BIOMEDICAL COMPANY, LLCGIS2017-01-13
10859394006191FIB CalibratorR 2 DIAGNOSTICS, INC.GIS2016-11-15
00859394006040FibrotekR 2 DIAGNOSTICS, INC.GIS2016-11-15
00817089020672DiazymeDIAZYME LABORATORIES, INC.GIS2016-11-03
00817089020689DiazymeDIAZYME LABORATORIES, INC.GIS2016-11-03
00842768021138N/T Protein Control PYSiemens Healthcare Diagnostics Products GmbHGIL2016-09-24
08426950573494HemosIL Q.F.A. Thrombin (Bovine) - 5 mLINSTRUMENTATION LABORATORY COMPANYGIS2016-09-23
08426950573500HemosIL Q.F.A. Thrombin (Bovine) - 2 mLINSTRUMENTATION LABORATORY COMPANYGIS2016-09-23
00845275000580Thermo Scientific Pacific Hemostasis®Fisher DiagnosticsGIS2016-09-16
00845275000597Thermo Scientific Pacific Hemostasis®Fisher DiagnosticsGIS2016-09-16
00845275000627Thermo Scientific Pacific Hemostasis®Fisher DiagnosticsGIS2016-09-16
00845275000825Thermo Scientific Pacific Hemostasis®Fisher DiagnosticsGIS2016-09-16
00845275000849Thermo Scientific Pacific Hemostasis®Fisher DiagnosticsGIS2016-09-16
00845275000856Thermo Scientific Pacific Hemostasis®Fisher DiagnosticsGIS2016-09-16
00816426020214K-ASSAY® Fibrinogen Reagent + CalibratorKAMIYA BIOMEDICAL COMPANY, LLCGIS2016-09-16
00816426020351K-ASSAY® Fibrinogen Reagent (L)KAMIYA BIOMEDICAL COMPANY, LLCGIS2016-09-16
00816426020658K-ASSAY® Fibrinogen CalibratorKAMIYA BIOMEDICAL COMPANY, LLCGIS2016-09-16