FDA.reportPublic FDA data

FINDER G6PD

Primary DI
10819704020361
Brand
FINDER G6PD
Company
Baebies, Inc.
Model
100-000039
Catalog number
100-000039
Device description
FINDER G6PD Test
Published
2026-09-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
JBFGlucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JBFGlucose-6-Phosphate Dehydrogenase (Erythrocytic), ScreeningHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10819704020361PrimaryGS10
00819704020364Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081970402036110819704020361
00819704020364008197040203648197040203640819704020364

GMDN Terms#

Term, Definition table
TermDefinition
Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, kit, enzyme fluorescenceA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of glucose-6-phosphate dehydrogenase (G6PD) enzyme activity of red cells from a clinical specimen, using an enzyme fluorescence method.

Regulatory Flags#

DUNS number
079264306
Device count
16
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00819704020616FINDER Cleaning Accessory100-000031100-0000312026-07-27
00819704020074FINDER Instrument100-000054100-0000542026-05-01
00819704020425FINDER Flu A&B/SARS-CoV-2 Test100-000068100-0000682026-05-01
00819704020463FINDER Cleaning Accessory100-000061100-0000612026-05-01
00819704020487FINDER RVP Buffer100-000076100-0000762026-05-01
00819704020630FINDER Flu A&B/SARS-CoV-2 Positive Control Swab100-000077100-0000772026-05-01
00819704020654FINDER Flu A&B/SARS-CoV-2 Negative Control Swab100-000078100-0000782026-05-01
00819704020272Baebies Stop Solution210537252018-12-12
00819704020296Baebies Extraction Solution211437262018-12-12
00819704020302Baebies 4-MU IDS364039512018-10-04
00819704020319Baebies 4-MU Dilution Set395239522018-10-04
00819704020326Baebies C-Stop Solution367339532018-10-04
00819704020333FINDER34092025-01-31
00819704020340FINDER100-0000092025-01-31
00819704020364FINDER110-0000142025-01-31
00819704020388FINDER100-0000202025-01-31
00819704020395FINDER800-0000872025-01-31
00819704020005SEEKER™080225732017-09-19
00819704020012SEEKER™030531402017-09-19
00819704020029SEEKER™130531412017-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00819704020616FINDER Cleaning AccessoryBaebies, Inc.JBF2026-07-27
00819704020333FINDERBaebies, Inc.JBF2025-01-31
00819704020340FINDERBaebies, Inc.JBF2025-01-31
00819704020364FINDERBaebies, Inc.JBF2025-01-31
00811727014139Pointe G6PD ReagentHORIBA INSTRUMENTS INCORPORATEDJBF2021-01-30
00811727015679Pointe G6PD ControlsHORIBA INSTRUMENTS INCORPORATEDJBF2021-01-30
10811877010705BinaxNOW® G6PDAlere Scarborough, Inc.JBF2016-09-03