JBFClass II
Glucose-6-phosphate Dehydrogenase (erythrocytic), Screening
Hematology · 21 CFR 864.7360
MDR events7All time
Recalls1All time
Registered firms6Currently listed
510(k) clearances5All time
Recent MDR events
7 adverse event reports on file
- BINAXNOW G6PD KITOct 27, 2023MalfunctionAbbott Diagnostics Scarborough, Inc.1221359-2023-01593
- BINAXNOW G6PD KITOct 27, 2023MalfunctionAbbott Diagnostics Scarborough, Inc.1221359-2023-01594
- BINAXNOW G6PD KITOct 27, 2023MalfunctionAbbott Diagnostics Scarborough, Inc.1221359-2023-01592
- BINAXNOW G6PD KITOct 27, 2023MalfunctionAbbott Diagnostics Scarborough, Inc.1221359-2023-01595
- BINAXNOW G6PD KITOct 26, 2021InjuryAbbott Diagnostics Scarborough, Inc.1221359-2021-03312
- BINAXNOW G6PD TESTJul 3, 2020InjuryAbbott Diagnostics Scarborough, Inc.1221359-2020-00125
- BINAXNOW G6PDDec 17, 2019InjuryAbbott Diagnostics Scarborough, Inc.1221359-2019-00088
Event type breakdown
Malfunction4
Injury3
Most-reported manufacturers
Recalls
1 recall events for this product code
Registered firms
6 firms currently registered for this product code
510(k) clearances
5 clearances for this product code
- Baebies, Inc.Sep 14, 2022
K201049 · FINDER G6PD
- Alere Scarborough, Inc.Jun 17, 2016
K161364 · BinaxNOW G6PD Test
- Binax, Inc.Oct 23, 2008
K080003 · BINAXNOW G6PD TEST
- Pointe Scientific, Inc.,Mar 31, 2003
K024006 · G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE
- Sigma Diagnostics, Inc.Jun 29, 1995
K933934 · GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY SCREENING TEST KIT NO. 202-A