FDA.reportPublic FDA data

SPOTCHECK

Primary DI
00725609000052
Brand
SPOTCHECK
Company
ASTORIA-PACIFIC, INC.
Model
80-4000-CA
Catalog number
80-4000-CA
Device description
Uridyltransferase 50 Hour Reagent Kit
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
KQPFluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KQPFluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl TransferaseClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K970277000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K970277000URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K)Astoria-Pacific, Inc.1997-12-11KQP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00725609000052PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00725609000052007256090000527256090000520725609000052

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
623238615
Device count
1
Kit
true
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
00197157079703ZAVATION RODZavation LLCKQP2026-05-12
M719GMSD65400TiLockGenesys Orthopedics Systems LLCKQP2017-12-13
00725609000014SPOTCHECKASTORIA-PACIFIC, INC.KQP2016-10-14
00725609000045SPOTCHECKASTORIA-PACIFIC, INC.KQP2016-10-14
00725609000069SPOTCHECKASTORIA-PACIFIC, INC.KQP2016-10-14
00725609000113SPOTCHECKASTORIA-PACIFIC, INC.KQP2016-10-14
00725609000120SPOTCHECKASTORIA-PACIFIC, INC.KQP2016-10-14
00725609000151SPOTCHECKASTORIA-PACIFIC, INC.KQP2016-10-14
00725609000168SPOTCHECKASTORIA-PACIFIC, INC.KQP2016-10-14
00725609000175SPOTCHECKASTORIA-PACIFIC, INC.KQP2016-10-14
00725609000182SPOTCHECKASTORIA-PACIFIC, INC.KQP2016-10-14
06438147001262Neonatal GALT kitWallac OyKQP2016-02-02
06438147001279Neonatal GALT kitWallac OyKQP2016-02-02
06438147321704GSP Neonatal GALT kit Wallac OyKQP2016-01-12