Fastect II Drug Screen Dipstick Test MF17

GUDID 00816565020922

PCP25 single drug dipstick test

AMEDITECH INC.

Phencyclidine (PCP) IVD, kit, immunochromatographic test (ICT) Phencyclidine (PCP) IVD, kit, immunochromatographic test (ICT) Phencyclidine (PCP) IVD, kit, immunochromatographic test (ICT) Phencyclidine (PCP) IVD, kit, rapid ICT, clinical Phencyclidine (PCP) IVD, kit, rapid ICT, clinical Phencyclidine (PCP) IVD, kit, rapid ICT, clinical Phencyclidine (PCP) IVD, kit, rapid ICT, clinical Phencyclidine (PCP) IVD, kit, rapid ICT, clinical Phencyclidine (PCP) IVD, kit, rapid ICT, clinical Phencyclidine (PCP) IVD, kit, rapid ICT, clinical Phencyclidine (PCP) IVD, kit, rapid ICT, clinical Phencyclidine (PCP) IVD, kit, rapid ICT, clinical Phencyclidine (PCP) IVD, kit, rapid ICT, clinical Phencyclidine (PCP) IVD, kit, rapid ICT, clinical Phencyclidine (PCP) IVD, kit, rapid ICT, clinical Phencyclidine (PCP) IVD, kit, rapid ICT, clinical Phencyclidine (PCP) IVD, kit, rapid ICT, clinical Phencyclidine (PCP) IVD, kit, rapid ICT, clinical Phencyclidine (PCP) IVD, kit, rapid ICT, clinical Phencyclidine (PCP) IVD, kit, rapid ICT, clinical Phencyclidine (PCP) IVD, kit, rapid ICT, clinical Phencyclidine (PCP) IVD, kit, rapid ICT, clinical Phencyclidine (PCP) IVD, kit, rapid ICT, clinical Phencyclidine (PCP) IVD, kit, rapid ICT, clinical Phencyclidine (PCP) IVD, kit, rapid ICT, clinical Phencyclidine (PCP) IVD, kit, rapid ICT, clinical Phencyclidine (PCP) IVD, kit, rapid ICT, clinical

Primary Device ID	00816565020922
NIH Device Record Key	5bb6c6b8-b0c9-4b73-9015-f9e3fd558965
Commercial Distribution Discontinuation	2018-04-27
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	Fastect II Drug Screen Dipstick Test
Version Model Number	MF17
Catalog Number	MF17
Company DUNS	010551716
Company Name	AMEDITECH INC.
Device Count	1
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	true
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	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx

Operating and Storage Conditions

Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816565020922 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K022355

FDA Product Code

LCM	Enzyme Immunoassay, Phencyclidine

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2018-07-06
Device Publish Date	2017-03-31

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