AA2 Hemo Control 5328

• FDA 510(k) K800854 decided 29 Apr 1980 Active
• FDA GUDID UDI-DI M52553280 listed 7 Sep 2016 Listed

1. 29 Apr 1980 Cleared FDA 510(k) K800854
2. 7 Sep 2016 Listed FDA GUDID M52553280

Trade name

AA2 Hemo Control

Generic name

Inherited haemoglobinopathy IVD, control

Model / reference

5328

Primary DI / UDI-DI

M52553280

510(k) Number

K800854 ↗

FDA product code

JBD

GMDN term

Inherited haemoglobinopathy IVD, control

Device class

Class II

Regulation number

864.7440

GUDID distribution status

In Commercial Distribution

Category: Inherited haemoglobinopathy IVD, control

Other devices filed under FDA product code JBD (SYSTEM, ANALYSIS, ELECTROPHORETIC HEMOGLOBIN).

• BECKMAN B-4 TEB BUFFER KIT by Beckman Instruments, Inc.
• ECA HEME BUFFER by Electrophoresis Corp. of America
• GELMAN GLYCO-PHORE BUFFER by Gelman Sciences, Inc.
• MICROGEL ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM, MICROGEL ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM by Interlab S.R.L.
• HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO) by Morax
• REDI-DISC HEMOGLOBIN GEL TUBE KIT by Miles Laboratories, Inc.
• CORNING NORMAL GLYCOSYLATED HEMOGLOBIN by Corning Medical & Scientific
• HEMOGLOBIN ELECTROPHORESIS CONTROL by Isolab, Inc.
• AUTOPHOR 128 by Gelman Sciences, Inc.
• HEMOGLOBIN A2 TESTING SYSTEM by Isolab, Inc.

• V8 AFSA2 Hemo Control 1812

  Class II

  FDA 510(k) K192931 Active Cleared 19 Apr 2022 GUDID on market

• V8 Nexus Hemoglobin UltraScreen 1828

  Class II

  FDA 510(k) K192931 Active Cleared 19 Apr 2022 GUDID on market

• A1AT Controls 3435

  Class I

  FDA 510(k) K213396 Active Cleared 13 Oct 2022 GUDID on market

• SPIFE A1AT Kit 552651

  Class II

  FDA 510(k) K213396 Active Cleared 13 Oct 2022 GUDID on market

See all devices from Helena Laboratories, Corp. →