FDA.report

Dimension® Flex® reagent cartridge BUN

Primary DI
00842768014116
Brand
Dimension® Flex® reagent cartridge BUN
Company
Siemens Healthcare Diagnostics Inc.
Model
10444969
Catalog number
DF21
Device description
Urea Nitrogen Flex® reagent cartridge, 480 tests
Published
2016-09-24
Public version status
Update
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
CDQUREASE AND GLUTAMIC DEHYDROGENASE, UREA NITROGEN

Product Code Classifications

CodeDeviceSpecialtyClass
CDQUrease And Glutamic Dehydrogenase, Urea NitrogenClinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842768014116PrimaryGS10
00630414004495Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768014116008427680141168427680141160842768014116
00630414004495006304140044956304140044950630414004495

GMDN Terms

TermDefinition
Urea IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of urea or urea nitrogen [also known as blood urea nitrogen (BUN)] in a clinical specimen, using an enzyme spectrophotometry method. It is typically used as an indicator of kidney function and/or to differentiate between prerenal and postrenal azotemia.

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
4
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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