FDA.reportPublic FDA data

Dimension Lipase (LIP) Flex reagent cartridge

Primary DI
00630414292748
Brand
Dimension Lipase (LIP) Flex reagent cartridge
Company
Siemens Healthcare Diagnostics Inc.
Model
11538126
Catalog number
DF56A
Device description
Dimension Lipase (LIP) Flex reagent cartridge, 120 tests
Published
2021-11-11
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
CHILIPASE-ESTERASE, ENZYMATIC, PHOTOMETRIC, LIPASE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CHILipase-Esterase, Enzymatic, Photometric, LipaseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414292748PrimaryGS10
00630414306247Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414292748006304142927486304142927480630414292748
00630414306247006304143062476304143062470630414306247

GMDN Terms#

Term, Definition table
TermDefinition
Lipase IVD, kit, spectrophotometryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of lipase in a clinical specimen, using a spectrophotometry method.

Storage And Handling#

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

Contacts#

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

Regulatory Flags#

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

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