FDA.reportPublic FDA data

SPOTCHECK

Primary DI
00725609000038
Brand
SPOTCHECK
Company
ASTORIA-PACIFIC, INC.
Model
80-3500-13K
Catalog number
80-3500-13K
Device description
G6PD 25 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
JBLGlucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JBLGlucose-6-Phosphate Dehydrogenase (Erythrocytic), QuantitativeHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K990957000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K990957000ASTORIA-PACIFIC SPOTCHECK G6PD KIT 50 HR, MODEL 80-3000-13KAstoria-Pacific, Inc.1999-05-11JBL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00725609000038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00725609000038007256090000387256090000380725609000038

GMDN Terms#

Term, Definition table
TermDefinition
Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, kit, enzyme fluorescenceA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of glucose-6-phosphate dehydrogenase (G6PD) enzyme activity of red cells from a clinical specimen, using an enzyme fluorescence method.

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
00725609000021SPOTCHECKASTORIA-PACIFIC, INC.JBL2016-10-14
05391516743228Trinity Biotech TRINITY BIOTECH PUBLIC LIMITED COMPANYJBL2016-09-23
05391516745680Trinity BiotechTRINITY BIOTECH PUBLIC LIMITED COMPANYJBL2016-09-23
05391516741552Trinity BiotechTRINITY BIOTECH PUBLIC LIMITED COMPANYJBL2016-08-01