FDA.reportPublic FDA data

ADVIA® Chemistry Alkaline Phosphatase (ALP_2c) Reagents

Primary DI
00630414600611
Brand
ADVIA® Chemistry Alkaline Phosphatase (ALP_2c) Reagents
Company
Siemens Healthcare Diagnostics Inc.
Model
10916067
Catalog number
10916067
Device description
Alkaline Phosphatase - ADVIA Chem. - Conc. RGT - 6x1240
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
CJOALPHA-NAPHTHYL PHOSPHATE, ALKALINE PHOSPHATASE OR ISOENZYMES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CJOAlpha-Naphthyl Phosphate, Alkaline Phosphatase Or IsoenzymesClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121907000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121907000DIMENSION ALKALINE PHOSPHATASE FLEX REAGENT CARTRIDGE, DIMENSION ALKALINE PHOSPHATASE CALIBRATORSiemens Healthcare Diagnostics2012-07-23CJO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414600611PrimaryGS10
00630414006178Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414600611006304146006116304146006110630414600611
00630414006178006304140061786304140061780630414006178

GMDN Terms#

Term, Definition table
TermDefinition
Alanine aminotransferase (ALT) IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of alanine aminotransferase (ALT) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not freeze
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
064608573
Device count
6
DM exempt
false
Premarket exempt
false
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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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414654102Atellica CH ALP_2cSiemens Healthcare Diagnostics Inc.CJO2026-04-08
00630414596419Atellica CH ALP_2cSiemens Healthcare Diagnostics Inc.CJO2017-12-21
00842768039010Dimension® Flex® reagent cartridge ALPISiemens Healthcare Diagnostics Inc.CJO2016-09-24
00842768039034Dimension Vista® Flex® reagent cartridge ALPISiemens Healthcare Diagnostics Inc.CJO2016-09-24