FDA.reportPublic FDA data

Albumin BCP (6x50 mL)

Primary DI
08058056681980
Brand
Albumin BCP (6x50 mL)
Company
SENTINEL CH. SPA
Model
C22856
Catalog number
C22856
Device description
The Albumin BCP (6x50 mL) assay is an in vitro diagnostic test used for the determination of albumin in human serum or plasma. The assay is intended for professional use only. For In Vitro Diagnostic use only.
Published
2020-02-24
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
CJWBromcresol Purple Dye-Binding, Albumin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CJWBromcresol Purple Dye-Binding, AlbuminClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193001000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193001000Albumin BCPSENTINEL CH. SpA2019-12-19CJW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08058056681980PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08058056681980080580566819808058056681980

GMDN Terms#

Term, Definition table
TermDefinition
Albumin 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 albumin in a clinical specimen.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume300Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store between 15 and 30 degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9999999999customerservice@sentinel.it

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08058056681232CeruloplasminA26842A268422016-07-29
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08058056685407Cystatin C Controls06T321006T32102025-09-16
08058056685414Cystatin C06T322006T32202025-09-16
08058056685421Cystatin C06T323006T32302025-09-16
08058056681973Albumin BCP (6x20 mL)C22855C228552020-02-24
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
08058056681911CRP Ultra (MP)1156461156462018-02-27

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00380740155483ARCHITECTABBOTT IRELANDCJW2024-08-15
00380740155490ARCHITECTABBOTT IRELANDCJW2024-08-15
08058056681973Albumin BCP (6x20 mL)SENTINEL CH. SPACJW2020-02-24
00380740121723AlinityAbbott GmbHCJW2018-07-11
00630414595825Atellica CH AlbPSiemens Healthcare Diagnostics Inc.CJW2017-12-22
00842768005343Dimension® Flex® reagent cartridge ALBSiemens Healthcare Diagnostics Inc.CJW2016-09-24
00842768015021Dimension Vista® Flex® reagent cartridge ALBSiemens Healthcare Diagnostics Inc.CJW2016-09-24
00630414947402ADVIA® Chemistry Albumin BCP ReagentsSiemens Healthcare Diagnostics Inc.CJW2016-09-24
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04015630928064Albumin BCPRoche Diagnostics GmbHCJW2016-09-20
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00851445007006GENCHEM™ Albumin ReagentGENCHEM INCCJW2016-09-19
05055273200034ALBRANDOX LABORATORIES LIMITEDCJW2016-09-16
00817302020229CAROLINA LIQUID CHEMISTRIES CORP.™ ALB ALBUMIN REAGENT CC214CAROLINA LIQUID CHEMISTRIES CORPORATIONCJW2016-09-01
00817302020946CAROLINA LIQUID CHEMISTRIES CORP.® ALB RGT.KIT AU-214CAROLINA LIQUID CHEMISTRIES CORPORATIONCJW2016-09-01
15099590233341SynchronBeckman Coulter, Inc.CJW2016-08-24
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