FDA.report

Atellica CH Lip

Primary DI
00630414596358
Brand
Atellica CH Lip
Company
Siemens Healthcare Diagnostics Inc.
Model
11097606
Catalog number
11097606
Device description
Lipase (Lip) Atellica CH - RGT 1280T
Published
2020-09-24
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
false

Related Records

Contact Domains

Product Codes

CodeName
CHILIPASE-ESTERASE, ENZYMATIC, PHOTOMETRIC, LIPASE

Product Code Classifications

CodeDeviceSpecialtyClass
CHILipase-Esterase, Enzymatic, Photometric, LipaseClinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00630414596358PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414596358006304145963586304145963580630414596358

GMDN Terms

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

TypeLowHighCondition
Special Storage Condition, Specify00Protect From Light
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(877)229-3711XX@XX.XX
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags

DUNS number
064608573
Device count
1
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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