FDA.reportPublic FDA data

FINDER

Primary DI
00819704020364
Brand
FINDER
Company
Baebies, Inc.
Model
110-000014
Device description
FINDER G6PD TEST (Unit of Use)
Published
2025-01-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201049000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201049000FINDER G6PDBaebies, Inc.2022-09-14JBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00819704020364PrimaryGS10

Alternate GTIN / UPC / EAN Codes

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 (919) 420-3329findsupport@baebies.com

Regulatory Flags#

DUNS number
079264306
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00819704020388FINDER100-0000202025-01-31
00819704020395FINDER800-0000872025-01-31
00819704020005SEEKER™080225732017-09-19
00819704020012SEEKER™030531402017-09-19
00819704020029SEEKER™130531412017-09-19
00819704020036Baebies097409742018-01-18
00819704020043Baebies097509752018-01-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00819704020333FINDERBaebies, Inc.JBF2025-01-31
00819704020340FINDERBaebies, 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