SPOTCHECK

Primary DI
00725609000458
Brand
SPOTCHECK
Company
ASTORIA-PACIFIC, INC.
Model
80-0901-01K
Catalog number
80-0901-01K
Device description
Negative Control Card
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
JJTEnzyme Controls (Assayed And Unassayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJTEnzyme Controls (Assayed And Unassayed)Clinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090940000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090940000SPOTCHECK BLOOD SPOT CONTROL, ASSAYEDAstoria-Pacific, Inc.2009-12-14JJT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00725609000458PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00725609000458007256090004587256090004580725609000458

GMDN Terms#

Term, Definition table
TermDefinition
Multiple clinical chemistry enzyme IVD, controlA material which is used to verify the performance of a number of assays intended to be used for the quantitative measurement of one or multiple clinical chemistry enzymes.

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
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
00725609000328SPOTCHECK303-A004-03303-A004-032016-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00380740156381ARCHITECTABBOTT LABORATORIESJJT2020-03-03
00380740156398ARCHITECTABBOTT LABORATORIESJJT2020-03-03
04015630947119PreciControl ISDRoche Diagnostics GmbHJJT2019-01-14
04015630947126CalCheck ISDRoche Diagnostics GmbHJJT2019-01-14
00380740044831ARCHITECTABBOTT LABORATORIESJJT2018-07-31
00380740045593ARCHITECTABBOTT LABORATORIESJJT2018-07-31
00856743007024Cardiac Control MarkerMORE DIAGNOSTICS INCJJT2018-03-31
00856743007031Cardiac Marker ControlMORE DIAGNOSTICS INCJJT2018-03-31
00856743007048Cardiac Marker ControlMORE DIAGNOSTICS INCJJT2018-03-31
00893038002524Alere Cholestech LDX®Alere San Diego, Inc.JJT2018-03-30
00856743007017Cardiac Marker ControlMORE DIAGNOSTICS INCJJT2018-03-30
M52551340CK/LD Isoenzyme Control (5 x 2 mL)HELENA LABORATORIES CORPORATIONJJT2017-03-17
00847661001225LiquichekBIO-RAD LABORATORIES, INC.JJT2017-01-09
00847661001232LiquichekBIO-RAD LABORATORIES, INC.JJT2017-01-09
00847661002154LiquichekBIO-RAD LABORATORIES, INC.JJT2017-01-09
00852553007049Enzymer Verifier KitVERICHEM LABORATORIES, INC.JJT2016-11-29
00852553007056Enzymer ER Verifier KitVERICHEM LABORATORIES, INC.JJT2016-11-29
00852553007131Enzymer ER Verifier, Level GVERICHEM LABORATORIES, INC.JJT2016-11-29
00725609000205SPOTCHECKASTORIA-PACIFIC, INC.JJT2016-10-14
00725609000212SPOTCHECKASTORIA-PACIFIC, INC.JJT2016-10-14
00725609000441SPOTCHECKASTORIA-PACIFIC, INC.JJT2016-10-14
00384840518902Prodigy AutoCode Blood Glucose Monitoring SystemProdigy Diabetes Care, LLCJJT2016-09-22
00038481518505Prodigy AutoCode Blood Glucose Monitoring SystemPRODIGY DIABETES CARE, LLCJJT2016-09-22