FDA.reportPublic FDA data

FINDER

Primary DI
00819704020685
Brand
FINDER
Company
Baebies, Inc.
Model
4242.3
Catalog number
100-000082
Device description
FINDER Instrument
Published
2026-10-01
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
QOFMulti-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QOFMulti-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial AgentsMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K261837000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K261837000FINDER Flu A&B/SARS-CoV-2 TestBaebies, Inc.2026-09-11QOF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20819704020689PackageGS11In Commercial Distribution
00819704020685PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081970402068920819704020689
00819704020685008197040206858197040206850819704020685

GMDN Terms#

Term, Definition table
TermDefinition
Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple types of microorganisms (bacteria, fungi and/or viruses) associated with respiratory disease in a clinical specimen, using a nucleic acid technique (NAT). Organisms detected may include (but are not limited to) Streptococcus pneumoniae, influenza A, respiratory syncytial viruses A and B, rhinovirus, Haemophilus influenzae, Mycoplasma pneumoniae, Staphylococcus aureus, and/or enterovirus.

Regulatory Flags#

DUNS number
079264306
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
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
10819704020361FINDER G6PD100-000039100-0000392026-09-25
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850025770019Fast PCR Mini Respiratory Panel Test DiscAutonomous Medical Devices IncorporatedQOF2026-08-26
00850025770088Fast PCR Mini Respiratory Panel Test Disc and Accessory Kits (qty 20)Autonomous Medical Devices IncorporatedQOF2026-08-26
00850025770156Fast PCR Mini Respiratory Panel Test Disc and Accessory Kits (qty 10)Autonomous Medical Devices IncorporatedQOF2026-08-26
00819704020074FINDER InstrumentBaebies, Inc.QOF2026-05-01
00819704020425FINDER Flu A&B/SARS-CoV-2 TestBaebies, Inc.QOF2026-05-01
00819704020463FINDER Cleaning AccessoryBaebies, Inc.QOF2026-05-01
00819704020487FINDER RVP BufferBaebies, Inc.QOF2026-05-01
00819704020630FINDER Flu A&B/SARS-CoV-2 Positive Control SwabBaebies, Inc.QOF2026-05-01
00819704020654FINDER Flu A&B/SARS-CoV-2 Negative Control SwabBaebies, Inc.QOF2026-05-01
05061098480025NuLexaLEX DIAGNOSTICS LIMITEDQOF2026-04-24
05061098480032NuLexaLEX DIAGNOSTICS LIMITEDQOF2026-04-24
00875197006377cobas® SARS-CoV-2 & Influenza A/B Quality Control KitRoche Molecular Systems, Inc.QOF2026-02-24
00875197007329cobas® Respiratory flex Control KitRoche Molecular Systems, Inc.QOF2026-02-24
00875197007541cobas® Respiratory 4-flexRoche Molecular Systems, Inc.QOF2026-02-24
20816101029031LIAISON NES® FLU A/B, RSV & COVID-19DIASORIN MOLECULAR LLCQOF2026-01-22
20816101029048LIAISON NES® FLU A/B, RSV & COVID-19 Control Swab KitDIASORIN MOLECULAR LLCQOF2026-01-22
20816101027358Simplexa COVID-19 / Flu A/B & RSV DirectDIASORIN MOLECULAR LLCQOF2026-01-14
20816101027365Simplexa COVID-19 / Flu A/B & RSV Positive Control PackDIASORIN MOLECULAR LLCQOF2026-01-14
04053228039402QIAstat-Dx® Respiratory Panel PlusQIAGEN GmbHQOF2025-09-25
14053228039409QIAstat-Dx® Respiratory Panel PlusQIAGEN GmbHQOF2025-09-25
00884999049369Alinity mABBOTT MOLECULAR INC.QOF2025-06-27
00884999049376Alinity mABBOTT MOLECULAR INC.QOF2025-06-27
00884999049383Alinity mABBOTT MOLECULAR INC.QOF2025-06-27
00875197006285cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid testRoche Molecular Systems, Inc.QOF2025-05-28
00875197007299cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid testRoche Molecular Systems, Inc.QOF2025-05-28
00875197007305cobas liat SARS-CoV-2, Influenza A/B & RSV control kitRoche Molecular Systems, Inc.QOF2025-05-28
00810031720019Visby Medical Respiratory Health Visby Medical, Inc.QOF2025-03-19
10810031720016Visby Medical Respiratory Health Visby Medical, Inc.QOF2025-03-19
10190302018982TaqPath™ COVID-19, Flu A, Flu B, RSV Select AssayLIFE TECHNOLOGIES CORPORATIONQOF2025-02-17
10190302018999TaqPath™ COVID-19, Flu A, Flu B, RSV Select Positive ControlLIFE TECHNOLOGIES CORPORATIONQOF2025-02-17