FDA.report

Direct Glycohemoglobin (HbA1c) Control Set

Primary DI
00657498000892
Brand
Direct Glycohemoglobin (HbA1c) Control Set
Company
STANBIO LABORATORY, L.P.
Model
0355-201
Catalog number
0355-201
Device description
For use as controls in the Quantitative Determination of Hemoglobin (HbA1c) in human blood.
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
LCPAssay, Glycosylated Hemoglobin

Product Code Classifications

CodeDeviceSpecialtyClass
LCPAssay, Glycosylated HemoglobinHematology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00657498000892PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00657498000892006574980008926574980008920657498000892

GMDN Terms

TermDefinition
Total haemoglobin (totHb) IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of total haemoglobin (totHb) in a clinical specimen.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
18005315535stanbiolab@ekfdiagnostics.com

Regulatory Flags

DUNS number
045361136
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00657498002094Uri-Trak 120 M Urine AnalyzerG1300-001G1300-0012023-06-08
00657498002322HGB Controls - Low3061-0033061-0032021-03-31
00657498002339HGB Controls - Low3061-0063061-0062021-03-31
00657498002346HGB Controls - Normal3062-0033062-0032021-03-31
00657498002353HGB Controls - Normal3062-0063062-0062021-03-31
00657498002360HGB Controls - High3063-0033063-0032021-03-31
00657498002377HGB Controls - High3063-0063063-0062021-03-31
00657498001806Standard 1A469-97A469-972016-09-24
00657498000199HemoPoint H2 DMSG3500-001G3500-0012016-09-24
00657498000380Excel® Chemistry AnalyzerG7700E-001G7700E-0012018-04-17
00657498000397Excel® Chemistry Analyzer (Spanish)G7700S-001G7700S-0012018-04-17
00657498002179STAT-Site WB Dual Analyte Measurement System7000-0017000-0012019-11-18
00657498002193STAT-Site WB Blood Glucose Test Strips7010-0257010-0252019-11-18
00657498002209STAT-Site WB Blood Glucose Test Strips7010-0507010-0502019-11-18
00657498002216STAT-Site WB Blood Glucose Test Strips7010-1007010-1002019-11-18
00657498002230STAT-Site WB B-Ketone Test Strips7020-0257020-0252019-11-18
00657498002247STAT-Site WB B-Ketone Test Strips7020-0507020-0502019-11-18
00657498002254STAT-Site WB B-Ketone Test Strips7020-1007020-1002019-11-18
00657498002261Blood Glucose Control Solution7014-2047014-2042019-11-18
00657498002278B-Ketone Control Solution7024-2047024-2042019-11-18

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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
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
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
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
03661540304675Direct A1c Reagent KitELITECHGROUP INC.LCP2023-10-01
10021292015029TRUE+ A1CNow Self CheckPOLYMER TECHNOLOGY SYSTEMS, INC.LCP2023-07-30
00086303000046OneDraw A1C Test SystemDRAWBRIDGE HEALTH, INC.LCP2022-05-13
00681131403252ReliOn™ 2CT A1C MeterWAL-MART STORES, INC.LCP2021-03-30
00811727016164Pointe HbA1c ReagentPOINTE SCIENTIFIC, INC.LCP2021-01-30
00630414977485IMMULITE® Systems COR Calibration Verification Material CortisolSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLCP2020-09-24
00817089021358DiazymeDIAZYME LABORATORIES, INC.LCP2020-07-21
00817089021365DiazymeDIAZYME LABORATORIES, INC.LCP2020-07-21
00817089021594DiazymeDIAZYME LABORATORIES, INC.LCP2020-07-21
00811727015853Pointe HbA1c for the BS480HORIBA INSTRUMENTS INCORPORATEDLCP2020-05-28