FDA.reportPublic FDA data

FMH RapidScreen

Primary DI
10888234000907
Brand
FMH RapidScreen
Company
IMMUCOR, INC.
Model
0007893
Catalog number
0007893
Device description
The FMH RapidScreen kit is intended for use in the detection of D-positive red blood cells in D-negative mothers.
Published
2016-04-14
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
LIMTest, Screening, For D Positive Fetal Rbc'S

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LIMTest, Screening, For D Positive Fetal Rbc'SHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK1100670

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK1100670

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888234000907PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088823400090710888234000907

GMDN Terms#

Term, Definition table
TermDefinition
Foeto-maternal haemorrhage/Kleihauer test 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 qualitative and/or quantitative detection of foetal red blood cells in a maternal clinical specimen, also known as a Kleihauer test, as an indicator of foeto-maternal haemorrhage.

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
08430793040051Aptiva® CTD Essential ReagentINOVA DIAGNOSTICS, INC.LIM2023-12-14
00816879020212Autostat II Anti-Nuclear Antibody (ANA) ScreenHYCOR BIOMEDICAL LLCLIM2016-09-26