FDA.report

HAEMOGLOBIN F AND A2 CONTROLS - LEVEL 1 AND 2 (Hb F & A2 CONTROL)

Primary DI
05055273208832
Brand
HAEMOGLOBIN F AND A2 CONTROLS - LEVEL 1 AND 2 (Hb F & A2 CONTROL)
Company
RANDOX LABORATORIES LIMITED
Model
HA5083
Published
2019-06-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
GGMControl, Hemoglobin

Product Code Classifications

CodeDeviceSpecialtyClass
GGMControl, HemoglobinHematology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05055273208832PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05055273208832050552732088325055273208832

GMDN Terms

TermDefinition
Multiple haemoglobin subtype 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 one or multiple subtypes of haemoglobin in a clinical specimen.

Sterilization Methods

Method

Regulatory Flags

DUNS number
227530649
Device count
1
DM exempt
false
Premarket exempt
true
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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05055273219050LIQUID CARDIAC CONTROL 2CQ10535CQ105352025-03-21
05055273219067LIQUID CARDIAC CONTROL 3CQ10536CQ105362025-03-21
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05055273219135LIQUID CARDIAC CONTROL LEVEL 2 (LIQUID CARDIAC CONTROL 2)CQ10617CQ106172025-03-21
05055273219142LIQUID CARDIAC CONTROL LEVEL 3 (LIQUID CARDIAC CONTROL 3)CQ10618CQ106182025-03-21
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05055273219166Assayed Liquid Chemistry Control Level 2 (ASY LIQ CHEM CONTROL 2)LAN105662025-03-21

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