FDA.reportPublic FDA data

Diazyme

Primary DI
00817089020672
Brand
Diazyme
Company
DIAZYME LABORATORIES, INC.
Model
DZ768A-K
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
GISTest, Fibrinogen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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
00817089020672PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817089020672008170890206728170890206720817089020672

GMDN Terms#

Term, Definition table
TermDefinition
Fibrinogen assay (factor I) IVD, kit, clottingA collection of reagents and other associated materials intended to be used for the quantitative measurement of fibrinogen (factor I) in a clinical specimen, using a clotting method.

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
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
00817089020689DiazymeDIAZYME LABORATORIES, INC.GIS2016-11-03
00817089020696DiazymeDIAZYME LABORATORIES, INC.GIS2016-11-03
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