FDA.reportPublic FDA data

Dimension® Flex® reagent cartridge TP

Primary DI
00842768005671
Brand
Dimension® Flex® reagent cartridge TP
Company
Siemens Healthcare Diagnostics Inc.
Model
10444979
Catalog number
DF73
Device description
Total Protein 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

Contact Domains#

Product Codes#

Code, Name table
CodeName
CEKBIURET (COLORIMETRIC), TOTAL PROTEIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CEKBiuret (Colorimetric), Total ProteinClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K950920000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K950920000DUPONT DIMENSION TOTAL PROTEIN METHODDupont Medical Products1995-08-11CEK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768005671PrimaryGS10
00630414004556Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768005671008427680056718427680056710842768005671
00630414004556006304140045566304140045560630414004556

GMDN Terms#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
005088112
Device count
4
Lot or batch
true
Expiration date on label
true

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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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