FDA.reportPublic FDA data

ABORhCard

Primary DI
00815312020000
Brand
ABORhCard
Company
MICRONICS, INC.
Model
BT-101-025
Catalog number
BT-101-025
Device description
Qualitative in vitro test that provides a simultaneous ABO and Rh determination of an individual's ABO and Rh status. Not for use in blood bank processing of blood products, for determining RHD status for the purpose of administering Rh immunoglobulin, or for screening purposes prior to transfusion. Single use device intended for individual blood group determination for educational and informational purposes. Each kit contains 25 tests.
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OQXSelf-Contained Blood Grouping

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OQXSelf-Contained Blood Grouping Hematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK1000080

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK1000080

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815312020000PrimaryGS10
00815312020048Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815312020000008153120200008153120200000815312020000
00815312020048008153120200488153120200480815312020048

GMDN Terms#

Term, Definition table
TermDefinition
ABO/Rh(D) multiple blood grouping IVD, kit, agglutinationA collection of immunoglobulins capable of binding to specific antigenic determinants and intended to be used together in testing a clinical specimen for a combination of one or multiple ABO system and/or Rh (D) (RH001) red blood cell antigens, using an agglutination method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00store at room temperatuire

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-855-895-9197support@micronics.net

Regulatory Flags#

DUNS number
799245519
Device count
25
Lot or batch
true
Expiration date on label
true