FDA.reportPublic FDA data

Alkaline phosphatase acc. to IFCC Gen.2

Primary DI
07613336120972
Brand
Alkaline phosphatase acc. to IFCC Gen.2
Company
Roche Diagnostics GmbH
Model
08056757190
Catalog number
08056757190
Published
2020-03-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
CJENITROPHENYLPHOSPHATE, ALKALINE PHOSPHATASE OR ISOENZYMES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CJENitrophenylphosphate, Alkaline Phosphatase Or IsoenzymesClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K033185000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K033185000COBAS INTEGRA ALP IFCC GEN.2Roche Diagnostics Corp.2003-10-14CJE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613336120972PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613336120972076133361209727613336120972

GMDN Terms#

Term, Definition table
TermDefinition
Total alkaline phosphatase (ALP) IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of total alkaline phosphatase (ALP) 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

Regulatory Flags#

DUNS number
315028860
Device count
1
Lot or batch
true
Expiration date on label
true

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Primary DI, Brand, Company table
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10673486001068Alkaline Phosphatase (Kinetic Procedure)TECO DIAGNOSTICSCJE2023-07-14
10673486002362Alkaline Phosphatase Liquid Reagent (Kinetic Procedure)TECO DIAGNOSTICSCJE2023-07-14
00811727016010Pointe Alkaline Phosphatase ReagentHORIBA INSTRUMENTS INCORPORATEDCJE2021-01-30
00811727015709Pointe Alkaline Phosphatase on the BS480HORIBA INSTRUMENTS INCORPORATEDCJE2020-05-28
03610230006832Yumizen C1200 ALPHORIBA ABX SASCJE2020-05-06
10758750031801VITROSORTHO-CLINICAL DIAGNOSTICS, INC.CJE2019-11-13
05055273208207ALKALINE PHOSPHATASE (ALP)RANDOX LABORATORIES LIMITEDCJE2019-06-03
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00380740150891ARCHITECTAbbott GmbHCJE2017-05-30
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00817302023015CAROLINA LIQUID CHEMISTRIES CORP.® ALP REAGENT PRODUCT NO. DT206CAROLINA LIQUID CHEMISTRIES CORPORATIONCJE2016-10-17
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