FDA.reportPublic FDA data

Dimension® Flex® reagent cartridge AHDL

Primary DI
00842768022029
Brand
Dimension® Flex® reagent cartridge AHDL
Company
Siemens Healthcare Diagnostics Inc.
Model
10464332
Catalog number
DF48B
Device description
High Density Lipoprotein Cholesterol Flex® reagent cartridge, 240 tests
Published
2020-09-24
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
JHMCOLORIMETRIC METHOD, LIPOPROTEINS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JHMColorimetric Method, LipoproteinsClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K073072000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K073072000DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48BDade Behring, Inc.2008-02-21JHM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768022029PrimaryGS10
00630414005553Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768022029008427680220298427680220290842768022029
00630414005553006304140055536304140055530630414005553

GMDN Terms#

Term, Definition table
TermDefinition
High density lipoprotein (HDL) cholesterol IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of high density lipoprotein (HDL) cholesterol lipid in a clinical specimen, using an enzyme 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
8
Lot or batch
true
Expiration date on label
true

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