FDA.reportPublic FDA data

PolyTiter

Primary DI
00855574005360
Brand
PolyTiter
Company
POLYMEDCO, INC.
Model
ANA-CAL
Device description
Anti Nuclear Antibody, Calibrator, PolyTiter
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
DHNAntinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DHNAntinuclear Antibody, Indirect Immunofluorescent, Antigen, ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K012163000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012163000POLYTITER SYSTEMPolymedco, Inc.2001-08-20DHN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855574005360PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855574005360008555740053608555740053600855574005360

GMDN Terms#

Term, Definition table
TermDefinition
Multiple antinuclear antibody (ANA) screening IVD, calibratorA material which is used to establish known points of reference for a number of assays intended to be used for the qualitative and/or quantitative screening for one or multiple antinuclear antibodies (ANA) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
024798555
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
00855574005377Poly statHCG-POC2016-09-23
00855574005384Poly statHCG252016-09-23
00855574005391Poly statHCG-POCU2016-09-23
00816917022925Poly statFLU252019-04-18
00855574005407Poly statFLU222016-09-23
00855574005414Poly statHP202016-09-23
00855574005421Poly statSTS252016-09-23
00855574005438Poly statSTF252016-09-23
00816917021546Poly statMN202016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250289504942AESKUSLIDES® ANA HEp-2-GammaAesku.Diagnostics GmbH & Co. KGDHN2025-05-27
04250289513487AESKUSLIDES® ANA-HEp-2 gamma Aesku.Diagnostics GmbH & Co. KGDHN2025-04-06
04250289513562AESKUSLIDES® ANA-HEp-2 gamma Aesku.Diagnostics GmbH & Co. KGDHN2025-04-06
08059304340215dIFine ANA HEp-2 ClassifierVISIA LAB SRLDHN2024-11-08
G5229023441ANA/HEp-2 IgG IFA 96 TestHemagen Diagnostics, Inc.DHN2023-10-05
G5229023451ANA/HEp-2 IgG IFA 180 TestHemagen Diagnostics, Inc.DHN2023-10-05
G5229023601ANA/HEp-2 IgG IFA 600 TestHemagen Diagnostics, Inc.DHN2023-10-05
G5229023701ANA/HEp-2 IgG IFA 1200 TestHemagen Diagnostics, Inc.DHN2023-10-05
G5229023901ANA/HEp-2 IgG IFA 120 TestHemagen Diagnostics, Inc.DHN2023-10-05
G5229024201Anti-nDNA IgG IFA 96 TestHemagen Diagnostics, Inc.DHN2023-10-05
08059304340109dIFine Automated Microscope VISIA LAB SRLDHN2022-09-07
00813545026561MeDiCaSCIMEDX CORPORATIONDHN2020-12-01
00813545026578MeDiCaSCIMEDX CORPORATIONDHN2020-12-01
00813545026905MeDiCaSCIMEDX CORPORATIONDHN2020-11-04
00813545026912MeDiCaSCIMEDX CORPORATIONDHN2020-11-04
04260186125096HELIOSAesku.Systems GmbH & Co. KGDHN2020-03-02
00845714002045Immco Diagnostics, IncIMMCO DIAGNOSTICS, INC.DHN2018-07-03
00845714002052Immco Diagnostics, Inc.IMMCO DIAGNOSTICS, INC.DHN2018-07-03
00845714002069Immco Diagnostics, Inc.IMMCO DIAGNOSTICS, INC.DHN2018-07-03
00845714004100Immco Diagnostics Inc.IMMCO DIAGNOSTICS, INC.DHN2018-07-03
00845714004117Immco Diagnostics, Inc.IMMCO DIAGNOSTICS, INC.DHN2018-07-03
04049016135722IFA 40: HEp-20-10 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGDHN2018-05-17
04049016135739IFA 40: HEp-20-10 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGDHN2018-05-17
04250289503020AESKULISA® ANA-HEp-2 Aesku.Diagnostics GmbH & Co. KGDHN2017-03-02
04250289503501AESKULISA® ANA HEp-2 Aesku.Diagnostics GmbH & Co. KGDHN2017-02-28
04250289504461AESKUSLIDES® ANA-HEp-2 Aesku.Diagnostics GmbH & Co. KGDHN2017-02-28
04250289504935AESKUSLIDES® ANA-HEp-2 gamma Aesku.Diagnostics GmbH & Co. KGDHN2017-02-28
10862534000331nDNA Test Kit ANTIBODIES INCORPORATEDDHN2016-12-20
10862534000300ANA Test Kit ANTIBODIES INCORPORATEDDHN2016-12-20
10862534000317ANA Test Kit ANTIBODIES INCORPORATEDDHN2016-12-20