FDA.reportPublic FDA data

FINDER Cleaning Accessory

Primary DI
00819704020616
Brand
FINDER Cleaning Accessory
Company
Baebies, Inc.
Model
100-000031
Catalog number
100-000031
Device description
FINDER Cleaning Accessory for use with FINDER Instrument Model 3409 only.
Published
2026-07-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
00819704020616PrimaryGS10
00819704020609Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819704020616008197040206168197040206160819704020616
00819704020609008197040206098197040206090819704020609

GMDN Terms#

Term, Definition table
TermDefinition
Multiple clinical chemistry analyser IVD, point-of-careA portable, electrically-powered instrument intended to be used by health professionals at the point-of-care for the qualitative and/or quantitative in vitro detection of multiple clinical chemistry analytes in a clinical specimen, using one or more technology(ies) [e.g., microfluidics, electrometry, spectrophotometry, colorimetry, fluorimetry, radiometry, chemiluminescence]. Analytes detected may include electrolytes, specific proteins, clinical chemistry substrates (e.g., lipid profile), liver and/or cardiac function test analytes, and/or enzymes.

Regulatory Flags#

DUNS number
079264306
Device count
10
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
false
Expiration date on label
false
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
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
00819704020036Baebies097409742018-01-18

Other Devices Sharing Product Codes#

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