FDA.report

HAEMOGLOBIN A1c (HbA1c)

Primary DI
05055273203554
Brand
HAEMOGLOBIN A1c (HbA1c)
Company
RANDOX LABORATORIES LIMITED
Model
HA3450
Catalog number
HA3450
Published
2019-06-03
Public version status
New
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

Product Codes

CodeName
LCPAssay, Glycosylated Hemoglobin

Product Code Classifications

CodeDeviceSpecialtyClass
LCPAssay, Glycosylated HemoglobinHematology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05055273203554PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05055273203554050552732035545055273203554

GMDN Terms

TermDefinition
Glycated haemoglobin (HbA1c) IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of glycated haemoglobin (HbA1c), also known as glycosylated haemoglobin in a clinical specimen.

Sterilization Methods

Method

Regulatory Flags

DUNS number
227530649
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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

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05055273210125LIQUID IMMUNOASSAY CONTROL - LEVEL 3 (IA CONTROL 3)LIA5144LIA51442025-03-24
05055273219814PTH CONTROL LEVEL 1 (PTH CONTROL 1)PTH10608PTH106082025-03-24
05055273219821PTH CONTROL LEVEL 2 (PTH CONTROL 2)PTH10609PTH106092025-03-24
05055273219838PTH CONTROL LEVEL 3 (PTH CONTROL 3)PTH10610PTH106102025-03-24
05055273219043LIQUID CARDIAC CONTROL 1CQ10534CQ105342025-03-21
05055273219050LIQUID CARDIAC CONTROL 2CQ10535CQ105352025-03-21
05055273219067LIQUID CARDIAC CONTROL 3CQ10536CQ105362025-03-21
05055273219128LIQUID CARDIAC CONTROL LEVEL 1 (LIQUID CARDIAC CONTROL 1)CQ10616CQ106162025-03-21
05055273219135LIQUID CARDIAC CONTROL LEVEL 2 (LIQUID CARDIAC CONTROL 2)CQ10617CQ106172025-03-21
05055273219142LIQUID CARDIAC CONTROL LEVEL 3 (LIQUID CARDIAC CONTROL 3)CQ10618CQ106182025-03-21
05055273219159Assayed Liquid Chemistry Control Level 1 (ASY LIQ CHEM CONTROL 1)LAL10565LAL105652025-03-21
05055273219166Assayed Liquid Chemistry Control Level 2 (ASY LIQ CHEM CONTROL 2)LAN105662025-03-21
05055273219173Assayed Liquid Chemistry Control Level 3 (ASY LIQ CHEM CONTROL 3)LAE10567LAE105672025-03-21
05055273219180Assayed Liquid Chemistry Control Level 1 (ASY LIQ CHEM CONTROL 1)LAL10625 LAL10625 2025-03-21
05055273219197Assayed Liquid Chemistry Control Level 2 (ASY LIQ CHEM CONTROL 2)LAN10626LAN106262025-03-21
05055273219203Assayed Liquid Chemistry Control Level 3 (ASY LIQ CHEM CONTROL 3)LAE10627LAE106272025-03-21
05055273220018PlaySafe™ SCK10690SCK106902024-10-01

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0456218540493790 Sample Loader TOSOH CORPORATIONLCP2026-01-05
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04562185405255TSKgel GR01 HbA1c ColumnTOSOH CORPORATIONLCP2026-01-05
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14562185405276GR01 HbA1c Elution Buffer No. 2TOSOH CORPORATIONLCP2026-01-05
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