STA® - Fibrinogen 5

GUDID 13607450006749

DIAGNOSTICA STAGO

Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting Fibrinogen assay (factor I) IVD, kit, clotting

Primary Device ID	13607450006749
NIH Device Record Key	4c3d6a53-9441-42bb-869a-e2dfefae36d2
Commercial Distribution Status	In Commercial Distribution
Brand Name	STA® - Fibrinogen 5
Version Model Number	00674
Company DUNS	262277122
Company Name	DIAGNOSTICA STAGO
Device Count	12
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Operating and Storage Conditions

Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03607450006742 [Unit of Use]
GS1	13607450006749 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K840211

FDA Product Code

KQJ	SYSTEM, FIBRINOGEN DETERMINATION

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2016-09-15

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