ELUENT 80A

GUDID 14987486015090

These products are used with the ADAMS A1c HA-8180 series for the determination of Hemoglobin A1c (HbA1c) in human whole blood. These products are us

ARKRAY USA, INC.

Glycated haemoglobin (HbA1c) IVD, reagent
Primary Device ID14987486015090
NIH Device Record Key70705331-a1b8-4954-a44a-a50167cf668e
Commercial Distribution StatusIn Commercial Distribution
Brand NameELUENT 80A
Version Model Number103395
Company DUNS008171162
Company NameARKRAY USA, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-855-646-3108
Emailxxx@xxx.xxx

Operating and Storage Conditions

Storage Environment TemperatureBetween 3 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104987486015093 [Primary]
GS114987486015090 [Package]
Contains: 04987486015093
Package: Carton [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PDJHemoglobin A1c Test System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2018-02-08

Devices Manufactured by ARKRAY USA, INC.

00015482117313 - AUTION MAX™ AX-4060 Analyzer2024-12-10 The AUTION MAX AX-4060 urine analyzer, when used with AUTION Sticks 9EB test strips is a fully automated urinalysis sytem intend
00015482117344 - AUTION™ Sticks 9EB - Test Strips2024-12-10 AUTION Sticks 9EB test strips are test strips for the in vitro qualitative or semi-quantitative measurement of the following ana
00015482181550 - AUTION EYE™ Sheath Solution - 10L Bottle2024-12-10 AUTION EYE Sheath Solution is intended for in vitro diagnostic use with the AUTION EYE AI-4510 analyzer to identify formed parti
00015482181574 - AUTION EYE™ Control Solution H/L2024-12-10 AUTION EYE Control Solution H/L is intended for in vitro diagnostic use only for performing quality control procedures with the
00015482181598 - AUTION EYE™ Calibrator Focus/Calibrator2024-12-10 AUTION EYE Calibrator is intended for in vitro diagnostic use only for focusing and calibrating the AUTION EYE AI-4510.
00015482188627 - AUTION EYE™ AI-4510 Analyzer2024-12-10 The AUTION EYE AI-4510 Urine Particle Analysis System is a fully automated urine particle analyzer for in vitro diagnostic use.
14987486005299 - Concentrated Washing Solution 32024-12-10 A concentrated wash or cleaning solution intended to be used as a consumable reagent on-board an automated or semi-automated ins
00015482183103 - SPOTCHEM™ EZ Analyzer2024-05-31 Dry Chemistry Analyzer IVD, semi-automated

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.