Syphilis Control

GUDID 00850212007065

FUJIREBIO US, INC.

Treponema pallidum total antibody IVD, control Treponema pallidum total antibody IVD, control Treponema pallidum total antibody IVD, control Treponema pallidum total antibody IVD, control Treponema pallidum total antibody IVD, control Treponema pallidum total antibody IVD, control Treponema pallidum total antibody IVD, control Treponema pallidum total antibody IVD, control Treponema pallidum total antibody IVD, control Treponema pallidum total antibody IVD, control Treponema pallidum total antibody IVD, control Treponema pallidum total antibody IVD, control Treponema pallidum total antibody IVD, control Treponema pallidum total antibody IVD, control Treponema pallidum total antibody IVD, control

Primary Device ID	00850212007065
NIH Device Record Key	1a7d6d2a-aead-45f3-a7da-17a650ebfa62
Commercial Distribution Status	In Commercial Distribution
Brand Name	Syphilis Control
Version Model Number	2130170
Company DUNS	029385775
Company Name	FUJIREBIO US, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	true
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	false
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

Customer Support Contacts

Phone	800-531-7963
Email	customerservice@fdi.com
Phone	800-531-7963
Email	customerservice@fdi.com
Phone	800-531-7963
Email	customerservice@fdi.com
Phone	800-531-7963
Email	customerservice@fdi.com
Phone	800-531-7963
Email	customerservice@fdi.com
Phone	800-531-7963
Email	customerservice@fdi.com
Phone	800-531-7963
Email	customerservice@fdi.com
Phone	800-531-7963
Email	customerservice@fdi.com
Phone	800-531-7963
Email	customerservice@fdi.com
Phone	800-531-7963
Email	customerservice@fdi.com
Phone	800-531-7963
Email	customerservice@fdi.com
Phone	800-531-7963
Email	customerservice@fdi.com
Phone	800-531-7963
Email	customerservice@fdi.com
Phone	800-531-7963
Email	customerservice@fdi.com
Phone	800-531-7963
Email	customerservice@fdi.com

Device Dimensions

Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
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Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0

Operating and Storage Conditions

Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850212007065 [Primary]

FDA Product Code

OHQ	Multi-Analyte Controls Unassayed

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2018-03-29
Device Publish Date	2017-06-23

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