FDA.reportPublic FDA data

Emit II Plus Oxycodone Positive Control 300

Primary DI
00630414027975
Brand
Emit II Plus Oxycodone Positive Control 300
Company
Siemens Healthcare Diagnostics Inc.
Model
10720812
Catalog number
9T719UL
Device description
Emit II Plus Oxycodone Positive Control 300
Published
2018-06-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LASDrug specific control materials

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LASDrug Specific Control MaterialsClinical Toxicology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414027975PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414027975006304140279756304140279750630414027975

GMDN Terms#

Term, Definition table
TermDefinition
Oxycodone IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of oxycodone in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius8 Degrees Celsius
Special Storage Condition, Specify00Store upright. Do not freeze or expose to temperatures above 32°C (90°F).
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)227-8994XX@XX.XX
+1(800)227-8994CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
005088112
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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00842768016912Dimension® PBNP Calibrator10445008RC423A2016-09-24
00630414498942ADVIA® Chemistry ACET Acetaminophen Reagents1032738179891382016-09-24
00630414568768ADVIA® Chemistry BENZ_2 Benzodiazepine_2 Reagents10378760103787602016-09-24
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