FDA.reportPublic FDA data

Poly stat

Primary DI
00816917021546
Brand
Poly stat
Company
POLYMEDCO, INC.
Model
MN20
Device description
Mono, Immunochromatographic
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KTNSystem, Test, Infectious Mononucleosis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KTNSystem, Test, Infectious MononucleosisImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K961024000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K961024000BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WBPrinceton BioMeditech Corp.1997-02-04KTN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816917021546PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816917021546008169170215468169170215460816917021546

GMDN Terms#

Term, Definition table
TermDefinition
Epstein-Barr virus (EBV) heterophile antibody IVD, kit, immunochromatographic test (ICT), rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of heterophile antibodies produced in response to Epstein-Barr virus (EBV) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses for the rapid detection of infection with Epstein-Barr virus (EBV), the virus associated with infectious mononucleosis and glandular fever. It is not intended to be used for self-testing.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 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
00855574005360PolyTiterANA-CAL2016-09-23
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10673486014068Teco Diagnostics Infectious Mononucleosis (IM) Latex TestTECO DIAGNOSTICSKTN2026-05-21
20885380183635CARDINAL HEALTHCardinal Health 200, LLCKTN2022-08-29
10885380183638CARDINAL HEALTHCardinal Health 200, LLCKTN2022-08-29
00006136471196Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.KTN2017-10-27
00006136471202Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.KTN2017-10-27
00006136471301Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.KTN2017-10-27
00006136471318Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.KTN2017-10-27
00006136471325Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.KTN2017-10-27
M220P0800163Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.KTN2017-02-13
00742860100048MONO, MERIDIAN IMMUNO 25 Test KitSEKISUI DIAGNOSTICS, LLCKTN2017-01-10
20612479202775McKessonMCKESSON MEDICAL-SURGICAL INC.KTN2016-12-09
00722066000311Rapid ResponseBTNX IncKTN2016-10-25
30888277191895MEDLINEMEDLINE INDUSTRIES, INC.KTN2016-10-14
10888277191891MedlineMEDLINE INDUSTRIES, INC.KTN2016-10-14
10304040024130Henry ScheinHENRY SCHEIN, INC.KTN2016-09-24
10763924516299ACCUTEST Rapid Mono TestJANT PHARMACAL CORPORATIONKTN2016-09-24
10859035006191Wampole ColorCard® MonoALERE NORTH AMERICA, LLCKTN2016-09-24
00613647000281Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.KTN2016-09-24
20304040024137Henry ScheinHENRY SCHEIN, INC.KTN2016-09-24
10815845020000Clearview®Alere San Diego, Inc.KTN2016-09-24
10815845020017Acceava®Alere San Diego, Inc.KTN2016-09-24
10815845020062Signify®Alere San Diego, Inc.KTN2016-09-24
10859035006238Acceava® Mono CassetteALERE NORTH AMERICA, LLCKTN2016-09-24
00848838031588NAREMEL, INC.KTN2016-09-24
00848838031601NAREMEL, INC.KTN2016-09-24
00848838065262NAREMEL, INC.KTN2016-09-24
00848838065279NAREMEL, INC.KTN2016-09-24
00848838065385NAREMEL, INC.KTN2016-09-24
00848838076817NAREMEL, INC.KTN2016-09-24
20613647000285Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.KTN2016-09-24