FDA.report

Dimension Vista® Flex® reagent cartridge UCFP

Primary DI
00842768015502
Brand
Dimension Vista® Flex® reagent cartridge UCFP
Company
Siemens Healthcare Diagnostics Inc.
Model
10445168
Catalog number
K3026
Device description
Urinary/Cerebrospinal Fluid Protein Flex® reagent cartridge, 180 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
CEKBIURET (COLORIMETRIC), TOTAL PROTEIN

Product Code Classifications

CodeDeviceSpecialtyClass
CEKBiuret (Colorimetric), Total ProteinClinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842768015502PrimaryGS10
00630414005270Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768015502008427680155028427680155020842768015502
00630414005270006304140052706304140052700630414005270

GMDN Terms

TermDefinition
Total protein IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of total protein in a clinical specimen, using an enzyme spectrophotometry method.

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
2
DM exempt
false
Premarket exempt
true
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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