FDA.reportPublic FDA data

Anti-A1 Lectin (Dolichos biflorus) Blood Grouping Lectin

Primary DI
10888234000952
Brand
Anti-A1 Lectin (Dolichos biflorus) Blood Grouping Lectin
Company
IMMUCOR, INC.
Model
0012280
Catalog number
0012280
Device description
Anti-A1 Lectin (Dolichos biflorus) Blood Grouping Lectin is used to differentiate A1 red blood cells from those of other A subgroups in saline slide or tube tests. This is a lectin product. This product is in a single vial configuration.
Published
2016-04-15
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
KSILectins And Protectins

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KSILectins And ProtectinsHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK8300180

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK8300180

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888234000952PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088823400095210888234000952

GMDN Terms#

Term, Definition table
TermDefinition
Anti-A1 red blood cell grouping IVD, lectinLectin molecules extracted from Dolichos biflorus, capable of binding to specific antigenic determinants and intended to be used in testing a clinical specimen for group A1 [ABO004] red blood cell antigens, using an agglutination method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature1 Degrees Celsius10 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-855-466-8267tech_support@immucor.com

Regulatory Flags#

DUNS number
061446282
Device count
1
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10888234002291Capture LISS006690800669082022-09-03
10888234001027H.P.C. (Human Platelet Concentrate)005732000573202016-04-18
10888234002475ImmuLINK00303112024-12-05
10888234000495Red Blood Cell (RBC) Storage Solution000503600050362016-04-15
10888234001065Specimen Diluent006605200660522016-04-18
10888234001072Specimen Diluent006605300660532016-04-18
10888234001041Galileo Neo006459900645992016-04-18
10888234001584Galileo Echo008700000870002016-04-18
10888234001591CMT Plates008900000890002016-04-18
10888234002321NEO Iris006459700645972018-12-10
10888234002338Echo Lumena008699800869982018-06-01
10888234001546Capture-R Positive Control Serum (Weak), Capture-R Negative Control Serum006690200669022022-09-03
10888234001553Capture-R Select006690300669032022-09-03
10888234001560Capture-P006690400669042022-09-03
10888234001577Capture-P Positive Control Serum (Weak), Capture-P Negative Control Serum006690500669052022-09-03
10888234002307Capture-R Ready Indicator Red Cells006690700669072022-09-03
10888234002314Capture-P Indicator Red Cells006690600669062022-09-03
10888234001522Referencells006690000669002022-08-03
10888234001539Capture-R Ready-Screen 3006690100669012022-08-01
10888234002239Gamma-Clone Anti-Fya (Monoclonal) Blood Grouping Reagent10 mL size vial / 5mL fill volume00664302022-04-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060242471063ALBAlect Anti-A1 Dolichos biflorus Blood Grouping LectinALBA BIOSCIENCE LIMITEDKSI2016-09-24
10758750003143ORTHOORTHO-CLINICAL DIAGNOSTICS, INC.KSI2016-08-24
10888234000723Anti-H (Ulex europaeus)IMMUCOR, INC.KSI2016-04-15