FDA.report

Dimension® DOA-Negative Control

Primary DI
00842768005145
Brand
Dimension® DOA-Negative Control
Company
Siemens Healthcare Diagnostics Inc.
Model
10445032
Catalog number
DC44A
Device description
Drugs of Abuse Negative Control, 6x5mL
Published
2020-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
DIFDRUG MIXTURE CONTROL MATERIALS

Product Code Classifications

CodeDeviceSpecialtyClass
DIFDrug Mixture Control MaterialsClinical Toxicology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842768005145PrimaryGS10
00630414004624Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768005145008427680051458427680051450842768005145
00630414004624006304140046246304140046240630414004624

GMDN Terms

TermDefinition
Multiple drugs of abuse 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 one or multiple drugs of abuse in a clinical specimen.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)441-9250XX@XX.XX
+1(800)441-9250CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags

DUNS number
005088112
Device count
6
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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