FDA.reportPublic FDA data

Precise TypeTM HEA BeadCheck Kit

Primary DI
10888234102632
Brand
Precise TypeTM HEA BeadCheck Kit
Company
BIOARRAY SOLUTIONS LTD
Model
800-20236
Catalog number
800-20236
Published
2014-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
PFKQuality Control For Molecular Immunohematology Tests

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PFKQuality Control For Molecular Immunohematology TestsHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK1300500

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK1300500

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888234102632PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088823410263210888234102632

GMDN Terms#

Term, Definition table
TermDefinition
Multiple blood group genotyping IVD, controlA material which is used to verify the performance of an assay intended to be used to evaluate a clinical specimen to determine the genotype for one or multiple blood groups. The blood group systems to be genotyped may include Rhesus (CcDEe), Kell (K, k, Kp^a, Kp^b), Duffy (Fy^a, Fy^b, Fy^x), Kidd (Jk^a, Jk^b), Lewis (Le^a, Le^b), MNS (M, N, S, s, U), Xg (Xg^a), Dombrock (Do^a, Do^b), Colton (Co^a, Co^b), Cartwright (Yt^a, Yt^b), Lutheran (Lu^a, Lu^b) and/or Diego (Di^a, Di^b).

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
949103725
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
10888234100065Immucor Precise TypeTM Human Erythrocyte Antigen Molecular BeadChip Test Slides800-20202-08800-20202-082014-09-24
10888234100621Filled Vial, Clean-up, 330uL800-00191800-001912014-09-24
10888234100645Filled Vial, eMAPTM Elongation Mix800-00193800-001932014-09-24
10888234100669Filled Vial, HEA 1.2 PCR Mix800-00194800-001942014-09-24
10888234100683Filled Vial, Lambda Exonuclease800-00195800-001952014-09-24
10888234100836Filled Vial,Negative Control 1mL800-00287800-002872014-09-24
10888234100928Filled Vial,HotStarTaq DNA Polymerase800-10242800-102422014-09-24
10888234102298BeadCheck HEA Ref-pA, Bulk and Fill800-00228800-002282014-09-24
10888234102328BeadCheck HEA Ref-pB, Bulk and Fill800-00229800-002292014-09-24
10888234102618Immucor Precise TypeTM Human Erythrocyte Antigen Molecular BeadChip Test Plate800-20202-96800-20202-962014-09-24
10888234102670Carrier Box, ETC, Slide, IVD800-20301800-203012014-09-24
10888234102205BioArray Assay Imaging SystemTM (AIS) 400C790-20006790-200062014-09-24
10888234102212BioArray Assay Imaging System TM (AIS) 400C790-20006-RF790-20006-RF2015-12-28
10888234102229BioArray Assay Imaging System TM (AIS) 400D790-20016790-200162015-08-06
10888234102236BioArray Assay Imaging System TM (AIS) 400D790-20016-RF790-20016-RF2015-08-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197106756430CARDINAL HEALTHCardinal Health 200, LLCPFK2024-10-10
50197106756438CARDINAL HEALTHCardinal Health 200, LLCPFK2024-10-10
10197106478349CARDINAL HEALTHCardinal Health 200, LLCPFK2024-01-16
50197106478347CARDINAL HEALTHCardinal Health 200, LLCPFK2024-01-16
10197106531235CARDINAL HEALTHCardinal Health 200, LLCPFK2024-01-09
10197106408506CARDINAL HEALTHCardinal Health 200, LLCPFK2023-08-15
50197106408504CARDINAL HEALTHCardinal Health 200, LLCPFK2023-08-15
10195594046347CARDINAL HEALTHCardinal Health 200, LLCPFK2021-04-23
50195594046345CARDINAL HEALTHCardinal Health 200, LLCPFK2021-04-23
08437013457040ID CORE CONTROLPROGENIKA BIOPHARMA, SAPFK2018-12-02
10888234102298BeadCheck HEA Ref-pA, Bulk and FillBIOARRAY SOLUTIONS LTDPFK2014-09-24
10888234102328BeadCheck HEA Ref-pB, Bulk and FillBIOARRAY SOLUTIONS LTDPFK2014-09-24