FDA.reportPublic FDA data

SPOTCHECK

Primary DI
00725609000229
Brand
SPOTCHECK
Company
ASTORIA-PACIFIC, INC.
Model
80-8060-75K
Catalog number
80-8060-75K
Device description
Biotinidase PABA Stock Standard, 50 mL
Published
2016-10-14
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
NAKSystem,Test,Biotinidase

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NAKSystem, Test, BiotinidaseClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K010844000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K010844000ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13KAstoria-Pacific, Inc.2001-09-21NAK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00725609000229PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00725609000229007256090002297256090002290725609000229

GMDN Terms#

Term, Definition table
TermDefinition
Biotinidase IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of the enzyme biotinidase in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
623238615
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00725609000595SPOTCHECK81-2500-05K81-2500-05K2020-12-17
00725609000076SPOTCHECK80-8000-13K80-8000-13K2016-10-14
00725609000083SPOTCHECK80-8000-CA80-8000-CA2016-10-14
00725609000090SPOTCHECK81-2000-20K81-2000-20K2016-10-14
00725609000106SPOTCHECK81-2000-60K81-2000-60K2016-10-14
00725609000113SPOTCHECK81-4000-20K81-4000-20K2016-10-14
00725609000120SPOTCHECK81-4000-60K81-4000-60K2016-10-14
00725609000137SPOTCHECK81-8000-13K81-8000-13K2016-10-14
00725609000144SPOTCHECK81-8000-60K81-8000-60K2016-10-14
00725609000199Accuwell6020-20-EGAL6020-20-EGAL2016-10-14
00725609000205SPOTCHECK80-0900-01K80-0900-01K2016-10-14
00725609000212SPOTCHECK80-0901P4K80-0901P4K2016-10-14
00725609000267SPOTCHECK910-0500-00910-0500-002016-10-14
00725609000441SPOTCHECK80-0900P4K80-0900P4K2016-10-14
00725609000458SPOTCHECK80-0901-01K80-0901-01K2016-10-14
00725609000274SPOTCHECK302-A100-03302-A100-032016-10-14
00725609000281SPOTCHECK302-A100-03EX302-A100-03EX2016-10-14
00725609000298SPOTCHECK303-A000-03303-A000-032016-10-14
00725609000304SPOTCHECK303-A002-03303-A002-032016-10-14
00725609000311SPOTCHECK303-A003-03303-A003-032016-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00725609000076SPOTCHECKASTORIA-PACIFIC, INC.NAK2016-10-14
00725609000083SPOTCHECKASTORIA-PACIFIC, INC.NAK2016-10-14
00725609000137SPOTCHECKASTORIA-PACIFIC, INC.NAK2016-10-14
00725609000144SPOTCHECKASTORIA-PACIFIC, INC.NAK2016-10-14
00725609000236SPOTCHECKASTORIA-PACIFIC, INC.NAK2016-10-14
00725609000243SPOTCHECKASTORIA-PACIFIC, INC.NAK2016-10-14
00725609000250SPOTCHECKASTORIA-PACIFIC, INC.NAK2016-10-14
06438147291342Neonatal Biotinidase kitWallac OyNAK2016-01-12
06438147291359Neonatal Biotinidase kit Wallac OyNAK2016-01-12
06438147330911GSP Neonatal Biotinidase kitWallac OyNAK2016-01-12