Emit II Plus Oxycodone Positive Control 100 9T619UL

GUDID 00630414027999

Emit II Plus Oxycodone Positive Control 100

Siemens Healthcare Diagnostics Inc.

Oxycodone IVD, control Oxycodone IVD, control Oxycodone IVD, control Oxycodone IVD, control Oxycodone IVD, control Oxycodone IVD, control Oxycodone IVD, control Oxycodone IVD, control Oxycodone IVD, control Oxycodone IVD, control Oxycodone IVD, control Oxycodone IVD, control Oxycodone IVD, control Oxycodone IVD, control Oxycodone IVD, control Oxycodone IVD, control Oxycodone IVD, control Oxycodone IVD, control Oxycodone IVD, control Oxycodone IVD, control Oxycodone IVD, control Oxycodone IVD, control Oxycodone IVD, control Oxycodone IVD, control Oxycodone IVD, control Oxycodone IVD, control Oxycodone IVD, control Oxycodone IVD, control Oxycodone IVD, control Oxycodone IVD, control Oxycodone IVD, control
Primary Device ID00630414027999
NIH Device Record Keya9f475d7-017f-4277-af3d-b5234c826f33
Commercial Distribution StatusIn Commercial Distribution
Brand NameEmit II Plus Oxycodone Positive Control 100
Version Model Number10720810
Catalog Number9T619UL
Company DUNS005088112
Company NameSiemens Healthcare Diagnostics Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
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

Special Storage Condition, SpecifyBetween 0 and 0 *Store upright. Do not freeze or expose to temperatures above 32°C (90°F).
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright. Do not freeze or expose to temperatures above 32°C (90°F).
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright. Do not freeze or expose to temperatures above 32°C (90°F).
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright. Do not freeze or expose to temperatures above 32°C (90°F).
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright. Do not freeze or expose to temperatures above 32°C (90°F).
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright. Do not freeze or expose to temperatures above 32°C (90°F).
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright. Do not freeze or expose to temperatures above 32°C (90°F).
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright. Do not freeze or expose to temperatures above 32°C (90°F).
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright. Do not freeze or expose to temperatures above 32°C (90°F).
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright. Do not freeze or expose to temperatures above 32°C (90°F).
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright. Do not freeze or expose to temperatures above 32°C (90°F).
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright. Do not freeze or expose to temperatures above 32°C (90°F).
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright. Do not freeze or expose to temperatures above 32°C (90°F).
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright. Do not freeze or expose to temperatures above 32°C (90°F).
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright. Do not freeze or expose to temperatures above 32°C (90°F).
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright. Do not freeze or expose to temperatures above 32°C (90°F).
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright. Do not freeze or expose to temperatures above 32°C (90°F).
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright. Do not freeze or expose to temperatures above 32°C (90°F).
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright. Do not freeze or expose to temperatures above 32°C (90°F).
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright. Do not freeze or expose to temperatures above 32°C (90°F).
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright. Do not freeze or expose to temperatures above 32°C (90°F).
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright. Do not freeze or expose to temperatures above 32°C (90°F).
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright. Do not freeze or expose to temperatures above 32°C (90°F).
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright. Do not freeze or expose to temperatures above 32°C (90°F).
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright. Do not freeze or expose to temperatures above 32°C (90°F).
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright. Do not freeze or expose to temperatures above 32°C (90°F).
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright. Do not freeze or expose to temperatures above 32°C (90°F).
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright. Do not freeze or expose to temperatures above 32°C (90°F).
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright. Do not freeze or expose to temperatures above 32°C (90°F).
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright. Do not freeze or expose to temperatures above 32°C (90°F).
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright. Do not freeze or expose to temperatures above 32°C (90°F).
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright. Do not freeze or expose to temperatures above 32°C (90°F).
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright. Do not freeze or expose to temperatures above 32°C (90°F).
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright. Do not freeze or expose to temperatures above 32°C (90°F).
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store upright. Do not freeze or expose to temperatures above 32°C (90°F).
Storage 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
GS100630414027999 [Primary]

FDA Product Code

LASDrug specific control materials

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-07-10
Device Publish Date2018-06-09

Devices Manufactured by Siemens Healthcare Diagnostics Inc.

00630414624488 - ADVIA Centaur TSH3-Ultra II2024-05-30 TSH3-ULII ADVIA Centaur - RGT 500T
00630414624501 - ADVIA Centaur TSH3-Ultra II2024-05-30 TSH3-ULII ADVIA Centaur - RGT (REF) 2500T
00630414624518 - Atellica IM TSH3-Ultra II2024-05-30 TSH3-ULII Atellica IM - RGT 110T
00630414624525 - Atellica IM TSH3-Ultra II2024-05-30 TSH3-ULII Atellica IM – RGT 550T
00630414624532 - Atellica IM TSH3ULII MCM set2024-05-30 TSH3-ULII Atellica IM - Consumable MCM Set
00630414624693 - Atellica IM TSH3-Ultra II2024-05-30 TSH3-ULII Atellica IM - RGT (REF) 2750T
00630414624709 - ADVIA Centaur TSH3ULII MCM SET2024-05-30 TSH3-ULII ADVIA Centaur - Consumable MCM Set
00630414317434 - Clinistix Kidney Health Test System2024-05-13 Test Strips for the Determination of Albumin and Creatinine in Urine

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