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ABORhCard BT-101-025

by Micronics, Inc.

ABORhCard BT-101-025 is an ABO/Rh multiple blood grouping IVD (FDA Class II; FDA product code OQX, Self-Contained Blood Grouping) made by Micronics, Inc., listed under FDA premarket submission BK100008 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00815312020000), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) BK100008

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00815312020000 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberBK100008 Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA premarket submission BK100008 Active
  • FDA GUDID UDI-DI 00815312020000 listed 23 Sep 2016 Listed

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
ABORhCard
Generic name
ABO/Rh multiple blood grouping IVD, kit, agglutination
Model / Ref / Catalog
BT-101-025
Primary DI / UDI-DI
00815312020000
FDA product code
OQX
GMDN term
ABO/Rh multiple blood grouping IVD, kit, agglutination
Device class
Class II
Regulation number
864.9175
GUDID distribution status
In Commercial Distribution

Related devices

Category: ABO/Rh multiple blood grouping IVD, kit, agglutination

Other devices from Micronics, Inc.

Properties

  • Single use
  • Over-the-counter
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)