FDA.reportPublic FDA data

alpha 1-Acid Glycoprotein

Primary DI
08058056680648
Brand
alpha 1-Acid Glycoprotein
Company
SENTINEL CH. SPA
Model
A26838
Catalog number
A26838
Device description
The kit is intended for the quantitative determination of Alpha 1-Acid Glycoprotein (AGP) in serum and plasma by immunoturbidimetry. For In Vitro Diagnostic Use only.
Published
2017-05-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LKLAlpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LKLAlpha-1-Acid-Glycoprotein, Antigen, Antiserum, ControlImmunology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08058056680648PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08058056680648080580566806488058056680648

GMDN Terms#

Term, Definition table
TermDefinition
Alpha-1-acid glycoprotein (orosomucoid) 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 quantitative measurement of alpha-1-acid glycoprotein (orosomucoid) in a clinical specimen.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume88Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store between 2 and 8 degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
9999999999customerservice@sentinel.it

Regulatory Flags#

DUNS number
429572365
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

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08058056681232CeruloplasminA26842A268422016-07-29
08058056685391Cystatin C Calibrators06T320106T32012025-09-16
08058056685407Cystatin C Controls06T321006T32102025-09-16
08058056685414Cystatin C06T322006T32202025-09-16
08058056685421Cystatin C06T323006T32302025-09-16
08058056681973Albumin BCP (6x20 mL)C22855C228552020-02-24
08058056681980Albumin BCP (6x50 mL)C22856C228562020-02-24
08058056685438ARCHITECT c ACE Assay File6U82-1A6U82-1A2025-03-10
08058056685445Alinity c ACE Assay File06U86-1A06U86-1A2025-03-10
08058056685285ACE Calibrator06U820106U82012025-01-27
08058056685292ACE Control06U821006U82102025-01-27
08058056685308ACE Reagent06U822506U82252025-01-27
08058056685315ACE Calibrator06U860106U86012025-01-27
08058056685322ACE Control06U861006U86102025-01-27
08058056685339ACE Reagent06U862506U86252025-01-27
08058056680211Lp(a) Ultra11504D11504D2024-03-15
08058056680228Lp(a) Cal Set11522D11522D2024-03-15
08058056681744Lp(a) Control Set115220111522012024-03-15
08058056680181Ammonia Ultra 17660176602023-11-22
08058056680617Lipase Color Liquid17401B17401B2017-01-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04015630919529Tina-quant Alpha 1-Acid Glycoprotein Gen.2Roche Diagnostics GmbHLKL2021-02-08
04015630928408Tina-quant Alpha 1-Acid Glycoprotein Gen.2Roche Diagnostics GmbHLKL2021-01-18
00630414590158ADVIA® Chemistry AAG a1-Acid Glycoprotein ReagentsSiemens Healthcare Diagnostics Inc.LKL2020-09-24
00630414596211Atellica CH AAGSiemens Healthcare Diagnostics Inc.LKL2020-09-24
00842768005985Dimension Vista® a1-Acid Glycoprotein Flex® reagent cartridgeSiemens Healthcare Diagnostics Products GmbHLKL2020-09-24
07613336130162Tina-quant a1-Acid Glycoprotein Gen.2Roche Diagnostics GmbHLKL2020-03-05
00380740156428ARCHITECTABBOTT LABORATORIESLKL2020-03-03
05055273200126ALPHA-1-ACID-GLYCOPROTEIN (AGT)RANDOX LABORATORIES LIMITEDLKL2019-05-31
00380740153809AlinityABBOTT LABORATORIESLKL2019-04-10
00380740054168ARCHITECTABBOTT LABORATORIESLKL2018-07-31
15099590010591AUBECKMAN COULTER IRELAND INC.LKL2016-09-24
B1761230Antiserum to Human Alpha 1 Acid GlycoproteinKENT LABORATORIES INCLKL2016-09-24
05051700016537Human alpha 1 acid glycoprotein Kit for use on SPAPLUSTHE BINDING SITE GROUP LIMITEDLKL2016-09-24
05051700017633Optilite Alpha-1-Acid Glycoprotein KitTHE BINDING SITE GROUP LIMITEDLKL2016-09-24
00816426020146K-ASSAY® Alpha-1 AG ReagentKAMIYA BIOMEDICAL COMPANY, LLCLKL2016-09-16
15099590224066IMMAGEBeckman Coulter, Inc.LKL2016-08-24