FDA.reportPublic FDA data

Adsorb Out

Primary DI
00812117015255
Brand
Adsorb Out
Company
ONE LAMBDA, INC.
Model
N/A
Catalog number
ADSORB
Device description
To reduce high background that is caused by nonspecific binding of materials in human sera to the latex beads used in flow antibody detection assays.
Published
2018-06-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PPMGeneral Purpose Reagent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PPMGeneral Purpose ReagentPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812117015255PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812117015255008121170152558121170152550812117015255

GMDN Terms#

Term, Definition table
TermDefinition
DNA blocking reagent IVDA substance or reactant intended to be used to decrease the background noise caused by non-specific binding or hybridization, during the detection of nucleic acids in assays performed on a clinical specimen. Examples of blocking reagents may include (but are not limited to) Cot-1 DNA, tRNA and bovine serum albumin (BSA).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius-65 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800.822.88241lambda-TechSupport@thermofisher.com

Regulatory Flags#

DUNS number
118289289
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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Primary DIBrandModelCatalogPublished
00812117016818SeCore™ CDx HLA A Locus Sequencing KitSECCDX-ASECCDX-A2023-01-30
00812117016825SeCore™ CDx HLA GSSP KitSECCDX-GSSPSECCDX-GSSP2023-01-30
00812117016849uTYPE™ CDx HLA Sequence Analysis SoftwareUTPCDX-PGRUTPCDX-PGR2023-01-30
00814695024452Micro SSP™ Gel System - 108 WellsN/AMGS1082018-06-15
00812117015484PE-Conjugated StreptavidinN/ALSPSAB22020-06-04
00812117010199LABScreen™ Single Antigen HLA Class I ExPlexN/ALS1AEX012020-06-03
00812117014654LABScreen™ Single Antigen HLA Class II ExPlexN/ALS2AEX012020-06-03
00814695022496UniMatch™ Plus Software N/A7901112016-08-31
00812117015873Fluorobeads™ T Lymphocyte – 25 Isolations N/AFB1-252018-05-31
00812117015880Fluorobeads™ B Lymphocyte – 25 IsolationsN/AFB2-252018-05-31
00812117015897FluoroQuench Acridine Orange/Ethidium Bromide - 100mlN/AFQAE1002018-05-31
00812117016184FluoroQuench Acridine Orange/Ethidium Bromide - 500mlN/AFQAE5002018-05-31
00812117016207FluoroQuench Acridine Orange/Ethidium Bromide - 2000 mlN/AFQAE20002018-05-31
00812117016832Lympho-Kwik T/B Lymphocyte, 25 isolationsN/ALKTB252018-05-31
00812117018041Fluorobeads™ T Lymphocyte – 100 Isolations N/AFB1-1002018-05-31
00812117018058FluoroBeads™ T Developer (10X)N/AFB1-DEV2018-05-31
00812117018072Fluorobeads™ B Lymphocyte – 100 IsolationsN/AFB2-1002018-05-31
00812117018447FluoroQuench Plus Acridine Orange/Ethidium Bromide - 100 mlN/AFQZAE1002018-05-31
00812117018768Lympho-Kwik Mononuclear Cell, 50 isolationsN/ALK-50-MN2018-05-31
00812117018775Lympho-Kwik T Lymphocyte, 50 isolationsN/ALK-50-T2018-05-31

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