FDA.reportPublic FDA data

Hopkins Medical Products®

Primary DI
00817643020223
Brand
Hopkins Medical Products®
Company
HOPKINS UNIFORM COMPANY
Model
34265
Catalog number
34265
Device description
A1CNow+ and 20-Test Kit
Published
2018-09-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LCPASSAY, GLYCOSYLATED HEMOGLOBIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LCPAssay, Glycosylated HemoglobinHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090413000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090413000A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHECBayer Healthcare, LLC2009-05-14LCP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817643020223PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817643020223008176430202238176430202230817643020223

GMDN Terms#

Term, Definition table
TermDefinition
Glycated haemoglobin (HbA1c) monitoring system IVD, home-useA collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, and/or other associated disposable materials (e.g., lancet) intended to be used for the quantitative measurement of glycated haemoglobin (HbA1c) in a whole blood clinical specimen; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. The measurement is typically based on an immunological method (e.g., immunoassay) and/or spectrophotometry, and is used to evaluate the long-term control of blood glucose concentration, primarily in persons with diabetes mellitus.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)835-1995customerservice@hopkinsmedical.net

Regulatory Flags#

DUNS number
003080678
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817643020421Hopkins Medical Products®6103886103882018-09-28
00817643021701Hopkins Medical Products®7129177129172018-09-28
00817643021718Hopkins Medical Products®7129187129182018-09-28
00817643021732Hopkins Medical Products®34212342122018-09-28
00817643021749Hopkins Medical Products®34213342132018-09-28
00817643022173Hopkins Medical Products®6118066118062018-09-28
00817643022180Hopkins Medical Products®6121456121452018-09-28
00817643022197Hopkins Medical Products®6133036133032018-09-28
00817643020780Hopkins Medical Products®6942626942622018-09-28
00817643020797Hopkins Medical Products®6942636942632018-09-28
00817643020803Hopkins Medical Products®6942656942652018-09-28
00817643020810Hopkins Medical Products®6942726942722018-09-28
00817643020827Hopkins Medical Products®6942736942732018-09-28
00817643020834Hopkins Medical Products®6942756942752018-09-28
00817643020841Hopkins Medical Products®6948626948622018-09-28
00817643020858Hopkins Medical Products®6948636948632018-09-28
00817643020865Hopkins Medical Products®6948656948652018-09-28
00817643020964Hopkins Medical Products®6952626952622018-09-28
00817643020971Hopkins Medical Products®6952636952632018-09-28
00817643021039Hopkins Medical Products®6982876982872018-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380740208622ARCHITECTAbbott GmbHLCP2026-05-15
00380740208639AlinityAbbott GmbHLCP2026-05-15
00860004423409QvinQurasense, Inc.LCP2026-05-08
00860004423492QvinQurasense, Inc.LCP2026-05-08
04562185405262GR01 HbA1c Elution Buffer No. 1TOSOH CORPORATIONLCP2026-01-05
04562185405279GR01 HbA1c Elution Buffer No. 2TOSOH CORPORATIONLCP2026-01-05
04562185405286GR01 HbA1c Elution Buffer No. 3TOSOH CORPORATIONLCP2026-01-05
04562185400571HbA1c Diluting SolutionTOSOH CORPORATIONLCP2026-01-05
04562185404920Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01TOSOH CORPORATIONLCP2026-01-05
0456218540493790 Sample Loader TOSOH CORPORATIONLCP2026-01-05
04562185404944290 Sample LoaderTOSOH CORPORATIONLCP2026-01-05
04562185405255TSKgel GR01 HbA1c ColumnTOSOH CORPORATIONLCP2026-01-05
14562185405269GR01 HbA1c Elution Buffer No. 1TOSOH CORPORATIONLCP2026-01-05
14562185405276GR01 HbA1c Elution Buffer No. 2TOSOH CORPORATIONLCP2026-01-05
14562185405283GR01 HbA1c Elution Buffer No. 3TOSOH CORPORATIONLCP2026-01-05
04562185406207Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 LATOSOH CORPORATIONLCP2026-01-05
04713106028187URIGHT Hemoglobin A1c AnalyzerTAIDOC TECHNOLOGY CORPORATIONLCP2025-03-26
05391516749893Trinity BiotechPRIMUS CORPORATIONLCP2024-04-12
05391516749909Trinity BiotechPRIMUS CORPORATIONLCP2024-04-12
05391516749916Trinity BiotechPRIMUS CORPORATIONLCP2024-04-12
05391516749923Trinity BiotechPRIMUS CORPORATIONLCP2024-04-12
05391516749930Trinity Biotech PRIMUS CORPORATIONLCP2024-04-12
10304040178437Henry ScheinHENRY SCHEIN, INC.LCP2024-01-12
00304040178430Henry ScheinHENRY SCHEIN, INC.LCP2024-01-12
10673486001792Teco Diagnostics Hemoglobin A1c (HbA1c) Reagent SetTECO DIAGNOSTICSLCP2023-11-15
10673486001808Teco Diagnostics Hemoglobin A1c Set for TC Matrix SystemsTECO DIAGNOSTICSLCP2023-11-10
00381933080018A1CNow Self Check, 8ct.POLYMER TECHNOLOGY SYSTEMS, INC.LCP2023-10-25
10381933080015A1CNow Self Check, 8ct.POLYMER TECHNOLOGY SYSTEMS, INC.LCP2023-10-25
03661540304286Direct A1c Control KitELITECHGROUP INC.LCP2023-10-01
03661540304293Direct A1c Calibrator KitELITECHGROUP INC.LCP2023-10-01