FDA.reportPublic FDA data

Dimenison Vista Lipase Flex reagent cartridge

Primary DI
00630414306254
Brand
Dimenison Vista Lipase Flex reagent cartridge
Company
Siemens Healthcare Diagnostics Inc.
Model
11538128
Catalog number
K3056A
Device description
Dimenison Vista Lipase Flex reagent cartridge
Published
2021-11-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

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
00630414292762PrimaryGS10
00630414306254Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414292762006304142927626304142927620630414292762
00630414306254006304143062546304143062540630414306254

GMDN Terms#

Term, Definition table
TermDefinition
Lipase IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of lipase 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
4
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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