Emit® II Plus Opiate Assay 9B229

GUDID 00842768023354

Emit® II Plus Opiate Assay labeled with the Beckman Coulter® name

Siemens Healthcare Diagnostics Inc.

Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00842768023354
NIH Device Record Key1bd1546d-8370-4e44-817a-90948033abb4
Commercial Distribution StatusIn Commercial Distribution
Brand NameEmit® II Plus Opiate Assay
Version Model Number10445415
Catalog Number9B229
Company DUNS005088112
Company NameSiemens Healthcare Diagnostics Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)227-8994
EmailXX@XX.XX
Phone+1(800)227-8994
EmailXX@XX.XX
Phone+1(800)227-8994
EmailXX@XX.XX
Phone+1(800)227-8994
EmailXX@XX.XX
Phone+1(800)227-8994
EmailXX@XX.XX
Phone+1(800)227-8994
EmailXX@XX.XX
Phone+1(800)227-8994
EmailXX@XX.XX
Phone+1(800)227-8994
EmailXX@XX.XX
Phone+1(800)227-8994
EmailXX@XX.XX
Phone+1(800)227-8994
EmailXX@XX.XX
Phone+1(800)227-8994
EmailXX@XX.XX
Phone+1(800)227-8994
EmailXX@XX.XX
Phone+1(800)227-8994
EmailXX@XX.XX
Phone+1(800)227-8994
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)227-8994
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)227-8994
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)227-8994
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)227-8994
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)227-8994
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)227-8994
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)227-8994
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)227-8994
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)227-8994
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)227-8994
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)227-8994
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)227-8994
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)227-8994
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)227-8994
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)227-8994
EmailCONTACT@SIEMENS-HEALTHINEERS.COM

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100842768023354 [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 Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

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00630414317472 - Atellica Connect2024-09-19

Trademark Results [Emit]

Mark Image

Registration | Serial
Company
Trademark
Application Date
EMIT
EMIT
97319889 not registered Live/Pending
Multiple Axis LLC
2022-03-18
EMIT
EMIT
90597476 not registered Live/Pending
Addo, Anderson
2021-03-23
EMIT
EMIT
90332166 not registered Live/Pending
Emergency Medical Innovation Technology
2020-11-20
EMIT
EMIT
88517308 not registered Live/Pending
LEE, HYUNGSUK
2019-07-16
EMIT
EMIT
88231122 not registered Live/Pending
Emit Clothing LLC
2018-12-16
EMIT
EMIT
88009306 not registered Dead/Abandoned
Cantor, Eric A
2018-06-21
EMIT
EMIT
87788766 5560946 Live/Registered
SERVERLESS, INC.
2018-02-07
EMIT
EMIT
86568708 not registered Dead/Abandoned
Jigabot, LLC
2015-03-18
EMIT
EMIT
86396207 not registered Dead/Abandoned
Emit Creative LLC
2014-09-16
EMIT
EMIT
85912789 4872604 Live/Registered
EMIT Technologies, Inc.
2013-04-23
EMIT
EMIT
85792006 not registered Dead/Abandoned
Jigabot, LLC
2012-11-30
EMIT
EMIT
85116791 not registered Dead/Abandoned
STANZIALE, JR. CHARLES
2010-08-26

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