Fastect II Drug Screen Dipstick Test TF13

GUDID 00816565021240

THC50/COC300/OPI300 multiple drugs dipstick test

AMEDITECH INC.

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Primary Device ID00816565021240
NIH Device Record Keyaabff109-2e29-4ba6-8e30-d68286274aa9
Commercial Distribution Discontinuation2019-01-29
Commercial Distribution StatusNot in Commercial Distribution
Brand NameFastect II Drug Screen Dipstick Test
Version Model NumberTF13
Catalog NumberTF13
Company DUNS010551716
Company NameAMEDITECH INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100816565021240 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DJGEnzyme Immunoassay, Opiates

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-01-30
Device Publish Date2017-03-31

On-Brand Devices [Fastect II Drug Screen Dipstick Test]

00816565021240THC50/COC300/OPI300 multiple drugs dipstick test
00816565021035BZO300/COC300/OPI300/MTD300 multiple drugs dipstick test
00816565021028THC50/COC300/OPI300/MET300 multiple drugs dipstick test
00816565021011THC50/COC300/OPI300/BZO300 multiple drugs dipstick test
00816565021004BZO300/BAR300/MTD300/OXY100 multiple drugs dipstick test
00816565020991BUP10 single drug dipstick test
00816565020984OXY100 single drug dipstick test
00816565020977MDMA500 single drug dipstick test
00816565020960TCA1000 single drug dipstick test
00816565020953MTD300 single drug dipstick test
00816565020946BAR300 single drug dipstick test
00816565020939BZO300 single drug dipstick test
00816565020922PCP25 single drug dipstick test
00816565020915MET500 single drug dipstick test
00816565020908AMP1000 single drug dipstick test
00816565020892OPI300 single drug dipstick test
00816565020885COC300 single drug dipstick test
00816565020878THC50 single drug dipstick test
00816565020861THC50/COC300 multiple drugs dipstick test

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