Kit, MP Cotinine Serum 100 plate

GUDID 00608337000030

Orasure Technologies, Inc.

Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00608337000030
NIH Device Record Key66769f35-838a-430e-842f-74cdc1f87e2d
Commercial Distribution StatusIn Commercial Distribution
Brand NameKit, MP Cotinine Serum 100 plate
Version Model Number1124EC
Company DUNS114152184
Company NameOrasure Technologies, 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 Usefalse
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

Phone6108821820
Emailcustomercare@orasure.com
Phone6108821820
Emailcustomercare@orasure.com
Phone6108821820
Emailcustomercare@orasure.com
Phone6108821820
Emailcustomercare@orasure.com
Phone6108821820
Emailcustomercare@orasure.com
Phone6108821820
Emailcustomercare@orasure.com
Phone6108821820
Emailcustomercare@orasure.com
Phone6108821820
Emailcustomercare@orasure.com
Phone6108821820
Emailcustomercare@orasure.com
Phone6108821820
Emailcustomercare@orasure.com
Phone6108821820
Emailcustomercare@orasure.com
Phone6108821820
Emailcustomercare@orasure.com
Phone6108821820
Emailcustomercare@orasure.com
Phone6108821820
Emailcustomercare@orasure.com
Phone6108821820
Emailcustomercare@orasure.com
Phone6108821820
Emailcustomercare@orasure.com
Phone6108821820
Emailcustomercare@orasure.com
Phone6108821820
Emailcustomercare@orasure.com
Phone6108821820
Emailcustomercare@orasure.com
Phone6108821820
Emailcustomercare@orasure.com
Phone6108821820
Emailcustomercare@orasure.com
Phone6108821820
Emailcustomercare@orasure.com
Phone6108821820
Emailcustomercare@orasure.com
Phone6108821820
Emailcustomercare@orasure.com
Phone6108821820
Emailcustomercare@orasure.com
Phone6108821820
Emailcustomercare@orasure.com
Phone6108821820
Emailcustomercare@orasure.com
Phone6108821820
Emailcustomercare@orasure.com
Phone6108821820
Emailcustomercare@orasure.com
Phone6108821820
Emailcustomercare@orasure.com
Phone6108821820
Emailcustomercare@orasure.com
Phone6108821820
Emailcustomercare@orasure.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100608337000030 [Primary]

FDA Product Code

MKUEnzyme Immunoassay, Nicotine And Nicotine Metabolites

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-01
Device Publish Date2021-01-22

Devices Manufactured by Orasure Technologies, Inc.

10011822615393 - Rite Aid2021-04-07 Precision Freeze Wart Remover System
00608337000030 - Kit, MP Cotinine Serum 100 plate2021-02-01
00608337000030 - Kit, MP Cotinine Serum 100 plate2021-02-01
00608337001433 - OraQuick Ebola Rapid Antigen Test2020-03-09
20608337000119 - OraSure Oral Fluid Collection Device2019-03-11
00608337000863 - OraSure HIV-1 Western Blot Kit2018-09-14
20608337000065 - OraSure Quick Flu 22-Count Flu A + B Kit2018-07-06
00608337000009 - OraQuick Advance HIV 1/2 Kit Controls2018-07-06
20608337000010 - OraQuick Advance Rapid HIV 1/2 Antibody Test2018-07-06

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.