FDA.reportPublic FDA data

ADAMS™ A1c HA-8180V (UL) Analyzer

Primary DI
04987486001973
Brand
ADAMS™ A1c HA-8180V (UL) Analyzer
Company
Arkray USA, Inc.
Model
100675
Device description
The ADAMS A1c HA-8180V system is intended for the quantitative determination of hemoglobin A1c (IFCC mmol/mol and NGSP %) in human whole blood and hemolysate samples using Ion Exchange high performance liquid chromatography (HPLC).
Published
2017-12-08
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
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
PDJHemoglobin A1c Test System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PDJHemoglobin A1c Test SystemClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162822000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162822000ADAMS A1c HA-8180V, CALIBRATOR 80Arkray Factory, Inc.2017-06-29PDJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04987486001973PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04987486001973049874860019734987486001973

GMDN Terms#

Term, Definition table
TermDefinition
Glycated haemoglobin (HbA1C) analyser IVDA mains electricity (AC-powered) laboratory instrument intended to be used for the quantitative measurement of glycated haemoglobin (HbA1c), also known as glycohaemoglobin, glycosylated haemoglobin or glucosylated haemoglobin, in a clinical specimen. It typically uses a separation technique that is based on charge differences (i.e., ion-exchange chromatography, high pressure liquid chromatography, electrophoresis), chemical analysis (i.e., colorimetry, spectrophotometry), or structural differences (i.e., affinity chromatography and immunoassay).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Environment during transit (1-60 Degrees Celsius and 20-80% RH)
Storage Environment Humidity00
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
1-855-646-3108xxx@xxx.xxx

Regulatory Flags#

DUNS number
008171162
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380740208622ARCHITECTAbbott GmbHPDJ2026-05-15
00380740208639AlinityAbbott GmbHPDJ2026-05-15
04562185405262GR01 HbA1c Elution Buffer No. 1TOSOH CORPORATIONPDJ2026-01-05
04562185405279GR01 HbA1c Elution Buffer No. 2TOSOH CORPORATIONPDJ2026-01-05
04562185405286GR01 HbA1c Elution Buffer No. 3TOSOH CORPORATIONPDJ2026-01-05
04562185400571HbA1c Diluting SolutionTOSOH CORPORATIONPDJ2026-01-05
04562185404920Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01TOSOH CORPORATIONPDJ2026-01-05
0456218540493790 Sample Loader TOSOH CORPORATIONPDJ2026-01-05
04562185404944290 Sample LoaderTOSOH CORPORATIONPDJ2026-01-05
04562185405255TSKgel GR01 HbA1c ColumnTOSOH CORPORATIONPDJ2026-01-05
04562185406207Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 LATOSOH CORPORATIONPDJ2026-01-05
06935784430016BioHermes Automated Glycohemoglobin AnalyzerWuxi Biohermes Bio & Medical Technology Co.,Ltd.PDJ2022-01-04
07613336120927Tina-quant Hemoglobin A1cDx Gen.3Roche Diagnostics GmbHPDJ2020-04-14
07613336157824Tina-quant Hemoglobin A1cDx Gen.3Roche Diagnostics GmbHPDJ2020-04-14
07070060014555Afinion HbA1c DxAbbott Diagnostics Technologies ASPDJ2019-05-31
00380740135591AlinityAbbott GmbHPDJ2019-04-08
00630414220505Atellica CH A1c_ESiemens Healthcare Diagnostics Inc.PDJ2019-03-14
15099590012120AU BECKMAN COULTER IRELAND INC.PDJ2019-02-13
00630414006666Dimension Vista System Flex reagent cartridge A1C KITSiemens Healthcare Diagnostics Inc.PDJ2019-02-12
00630414006659Dimension Clinical Chemistry System A1C KitSiemens Healthcare Diagnostics Inc.PDJ2018-12-06
07070060012889Afinion HbA1c DxAbbott Diagnostics Technologies ASPDJ2018-11-01
00628063401147HbA1c AssaySekisui Diagnostics, LLCPDJ2018-09-24
00630414002859ADVIA Chemistry Enzymatic Hemoglobin A1cSiemens Healthcare Diagnostics Inc.PDJ2018-07-06
00630414002866ADVIA Chemistry Enzymatic Hemoglobin A1cSiemens Healthcare Diagnostics Inc.PDJ2018-07-06
00630414002880ADVIA Chemistry Enzymatic hemoglobin A1c PretreatmentSiemens Healthcare Diagnostics Inc.PDJ2018-07-06
04987486015093ELUENT 80AArkray USA, Inc.PDJ2018-02-08
04987486015109ELUENT 80BArkray USA, Inc.PDJ2018-02-08
04987486015116ELUENT 80CVArkray USA, Inc.PDJ2018-02-08
14987486015090ELUENT 80AARKRAY USA, INC.PDJ2018-02-08
14987486015106ELUENT 80BARKRAY USA, INC.PDJ2018-02-08