FDA.reportPublic FDA data

Diazyme

Primary DI
00817089020689
Brand
Diazyme
Company
DIAZYME LABORATORIES, INC.
Model
DZ768A-CAL
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
GFXFibrinogen Standard
GISTest, Fibrinogen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFXFibrinogen StandardHematology2
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
00817089020689PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817089020689008170890206898170890206890817089020689

GMDN Terms#

Term, Definition table
TermDefinition
Fibrinogen assay (factor I) IVD, calibratorA material which is used to establish known points of reference for 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
00817089020696DiazymeDZ768A-CON2016-11-03
00817089020863DiazymeDZ141A-CAL2016-11-03
00817089022539DiazymeDZ152A-CON2023-11-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414640631Fibrinogen Calibrator KitSiemens Healthcare Diagnostics Products GmbHGFX2024-03-25
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
00817089020696DiazymeDIAZYME LABORATORIES, INC.GIS2016-11-03
00842768008276Fibrinogen Calibrator KitSiemens Healthcare Diagnostics Products GmbHGFX2016-09-24
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