FDA.reportPublic FDA data

LABType™ SAPE Buffer

Primary DI
00814695023462
Brand
LABType™ SAPE Buffer
Company
ONE LAMBDA, INC.
Model
N/A
Catalog number
LTPSAPBUF-B
Device description
DNA typing of HLA Class I or Class II alleles.
Published
2016-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MZITest,Qualitative,For Hla,Non-Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MZITest, Qualitative, For Hla, Non-DiagnosticUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814695023462PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814695023462008146950234628146950234620814695023462

GMDN Terms#

Term, Definition table
TermDefinition
HLA class I & II antigen tissue typing IVD, kit, multiplexA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple HLA class I and II antigens in a clinical specimen, using a multiplex method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-80 Degrees Celsius-20 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800.822.8824techsupport@onelambda.com

Regulatory Flags#

DUNS number
118289289
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00812117015255Adsorb OutN/AADSORB2018-06-15
00814695024452Micro SSP™ Gel System - 108 WellsN/AMGS1082018-06-15
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
00812117018782Lympho-Kwik T/B Lymphocyte, 50 isolationsN/ALK-50-TB2018-05-31
00812117018799Lympho-Kwik T Lymphocyte, 25 isolationsN/ALKT252018-05-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00613745002446GenDx-LongMixGenbioMZI2025-12-27
00613745002453Nuclease-Free WaterGenbioMZI2025-12-27
00613745002491NGSgo-IndX Plate IIIGenbioMZI2025-12-27
00613745002576NGSgo-IndX Plate IIGenbioMZI2025-12-27
00613745002705 NGSgo-IndX Plate I (Indices Illumina)GenbioMZI2025-12-27
00613745003443NGSgo-IndX Illumina Adapter & Indices plate I (96) GenbioMZI2025-12-27
00613745003450NGSgo-IndX Illumina Adapter & Indices plate II (96) GenbioMZI2025-12-27
00613745003474NGSgo-IndX Illumina Adapter & Indices plate IV (96) GenbioMZI2025-12-27
00613745003481GenDx-AMPure XP - AMPure beads and elution buffer (5 ml) GenbioMZI2025-12-27
00613745003689NGS-Turbo® demo workflow reagentsGenbioMZI2025-12-27
00613745003702NGSgo® Pronto demo Workflow reagentsGenbioMZI2025-12-27
00613745003719NGSgo® Pronto demo Wash reagentsGenbioMZI2025-12-27
00613745001630NGSgo Library Full Kit for Illumina IndX Plate IIIGenbioMZI2025-12-26
00613745002293NGSgo Library Full Kit for Illumina IndX Plate IVGenbioMZI2025-12-26
00613745002309 NGSgo-AmpX v2 HLA GeneSuiteGenbioMZI2025-12-26
00613745002316NGSgo Library Full Kit for Illumina IndX Plate IGenbioMZI2025-12-26
00613745002323NGS-TurboAmp Multiplex 11 loci for ONT (12)GenbioMZI2025-12-26
00613745002330NGSgo-MX11-3GenbioMZI2025-12-26
00613745002347NGS-TurboPrep Library preparation for ONT(12)GenbioMZI2025-12-26
00613745002354NGSgo ProntoAmp HLA-A, B, C, DRB1, DQB1, DPB1, DRB3/4/5, DQA1, DPA1 (96)GenbioMZI2025-12-26
00613745002361NGSgo ProntoPrep HLA-A, B, C, DRB1, DQB1, DPB1, DRB3/4/5, DQA1, DPA1 (96)GenbioMZI2025-12-26
00613745002378NGSgo Library Full Kit for Illumina IndX plate IIGenbioMZI2025-12-26
00613745002606NGSgo-AmpX v2 HLA-BGenbioMZI2025-12-26
00613745002859AlleleSEQR® HLA-A PCR/Sequencing kit (25)GenbioMZI2025-12-26
00613745002866AlleleSEQR® HLA-B PCR/Sequencing kit (25) GenbioMZI2025-12-26
00613745002873AlleleSEQR® HLA-C PCR/Sequencing kit (25) GenbioMZI2025-12-26
00613745002880AlleleSEQR® HLA-DRB1 PCR/Sequencing kit (25) GenbioMZI2025-12-26
00613745002897AlleleSEQR® HLA-DQB1 PCR/Sequencing kit (25) GenbioMZI2025-12-26
00613745002903AlleleSEQR® HLA-DPB1 PCR/Sequencing kit (25) GenbioMZI2025-12-26
00613745002910KMRengine Chimerism monitoring software One year extension GenbioMZI2025-12-26