ABORhCard BT-101-025

GUDID 00815312020000

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.

MICRONICS, INC.

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Primary Device ID00815312020000
NIH Device Record Key72bfec55-35dd-4a06-abf9-e720c6e8f824
Commercial Distribution StatusIn Commercial Distribution
Brand NameABORhCard
Version Model NumberBT-101-025
Catalog NumberBT-101-025
Company DUNS799245519
Company NameMICRONICS, INC.
Device Count25
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone1-855-895-9197
Emailsupport@micronics.net
Phone1-855-895-9197
Emailsupport@micronics.net
Phone1-855-895-9197
Emailsupport@micronics.net
Phone1-855-895-9197
Emailsupport@micronics.net
Phone1-855-895-9197
Emailsupport@micronics.net
Phone1-855-895-9197
Emailsupport@micronics.net
Phone1-855-895-9197
Emailsupport@micronics.net
Phone1-855-895-9197
Emailsupport@micronics.net
Phone1-855-895-9197
Emailsupport@micronics.net
Phone1-855-895-9197
Emailsupport@micronics.net
Phone1-855-895-9197
Emailsupport@micronics.net
Phone1-855-895-9197
Emailsupport@micronics.net
Phone1-855-895-9197
Emailsupport@micronics.net
Phone1-855-895-9197
Emailsupport@micronics.net
Phone1-855-895-9197
Emailsupport@micronics.net
Phone1-855-895-9197
Emailsupport@micronics.net
Phone1-855-895-9197
Emailsupport@micronics.net
Phone1-855-895-9197
Emailsupport@micronics.net
Phone1-855-895-9197
Emailsupport@micronics.net

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperatuire
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperatuire
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperatuire
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperatuire
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperatuire
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperatuire
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperatuire
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperatuire
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperatuire
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperatuire
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperatuire
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperatuire
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperatuire
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperatuire
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperatuire
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperatuire
Special Storage Condition, SpecifyBetween 0 and 0 *store at room temperatuire

Device Identifiers

Device Issuing AgencyDevice ID
GS100815312020000 [Primary]
GS100815312020048 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OQXSelf-Contained Blood Grouping

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

Trademark Results [ABORhCard]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ABORHCARD
ABORHCARD
86615338 4944506 Live/Registered
PERKINELMER HEALTH SCIENCES, INC.
2015-04-30
ABORHCARD
ABORHCARD
77451216 3700486 Dead/Cancelled
Micronics, Inc.
2008-04-17
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