FDA.reportPublic FDA data

Baebies 6-HMU Dilution Set

Primary DI
00819704020289
Brand
Baebies 6-HMU Dilution Set
Company
Baebies, Inc.
Model
2110
Catalog number
2110
Device description
6-HMU Dilution SetGeneral Purpose Reagent, For Laboratory Use.
Published
2018-12-12
Public version status
Update
Distribution status
Not 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
PPMGeneral Purpose Reagent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PPMGeneral Purpose ReagentPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10819704020286PackageGS112In Commercial Distribution
00819704020289PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081970402028610819704020286
00819704020289008197040202898197040202890819704020289

GMDN Terms#

Term, Definition table
TermDefinition
Newborn metabolic screen/congenital disorder IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used in screening a clinical specimen for one or more congenital or metabolic disorders of the newborn. The test typically utilizes whole blood neonate specimens dried on filter paper, and the range of analytes detected may include neonatal thyroxine (neonatal T4), neonatal thyroid stimulating hormone (neonatal TSH), 17-hydroxyprogesterone, immunoreactive trypsinogen, various enzymes and/or amino acids, as indicators of congenital hypothyroidism, adrenal hyperplasia, cystic fibrosis, or other metabolic disorders.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-80 Degrees Celsius-70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
844-244-4034techsupport@baebies.com

Regulatory Flags#

DUNS number
079264306
Device count
1
Premarket exempt
true
Lot or batch
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
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
00846405012282Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405012299Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405012367Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405012374Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405012381Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405012398Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405012404Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405012480Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405014095Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405014132Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405014217Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405014224Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405016716Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405017065Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405017072Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405017089Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405017331Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405017362Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405019298Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405023233Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405023257Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405023264Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405023318Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405023325Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405023974Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405024421Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405020331Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-04-30
10845357044409Helix Elite™ Molecular Standards: Inactivated StandardMICROBIOLOGICS INC.PPM2026-04-15
08435804523417Master Polymer Plus Detection System (Phosphatase)VITRO SAPPM2026-04-07
08435804524551Master Polymer Plus Detection System (Phosphatase)VITRO SAPPM2026-04-07