FDA.reportPublic FDA data

Dimension® Flex® reagent cartridge CA

Primary DI
00842768014123
Brand
Dimension® Flex® reagent cartridge CA
Company
Siemens Healthcare Diagnostics Inc.
Model
10444949
Catalog number
DF23A
Device description
Calcium 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
CICCRESOLPHTHALEIN COMPLEXONE, CALCIUM
JJEANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CICCresolphthalein Complexone, CalciumClinical Chemistry2
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768014123PrimaryGS10
00630414004358Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768014123008427680141238427680141230842768014123
00630414004358006304140043586304140043580630414004358

GMDN Terms#

Term, Definition table
TermDefinition
Calcium (Ca2+) IVD, kit, spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of calcium (Ca2+) 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
8
Lot or batch
true
Expiration date on label
true

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00630414482309ADVIA® 1650 Chemistry System Ref.10309442103094422018-12-01
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