FDA.reportPublic FDA data

SEEKER™

Primary DI
00819704020180
Brand
SEEKER™
Company
Baebies, Inc.
Model
2115
Catalog number
2115
Device description
SEEKER™ LSD Reagent Kit - IDUA GAA
Published
2017-08-04
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
JIXCalibrator, Multi-Analyte Mixture
PPMGeneral Purpose Reagent
PQTAlpha-L-Iduronidase (Idua) Newborn Screening Test System
PQUAlpha-D-Glucosidase (Gaa) Newborn Screening Test System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JIXCalibrator, Multi-Analyte MixtureClinical Chemistry2
PPMGeneral Purpose ReagentPathology1
PQTAlpha-L-Iduronidase (Idua) Newborn Screening Test SystemClinical Chemistry2
PQUAlpha-D-Glucosidase (Gaa) Newborn Screening Test SystemClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN150035000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN150035000SEEKER SystemBaebies, Inc.2017-02-03PQW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00819704020180PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819704020180008197040201808197040201800819704020180

GMDN Terms#

Term, Definition table
TermDefinition
Newborn metabolic screen/congenital disorder IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in 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
Kit
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
04015630967162ISH Peroxidase InhibitorVentana Medical Systems, Inc.PPM2026-07-13
04049016151272FITC-labelled anti-human IgG (primate absorbed)EUROIMMUN Medizinische Labordiagnostika AGPPM2026-06-10
04049016151289Biotin-labelled anti-human IgGEUROIMMUN Medizinische Labordiagnostika AGPPM2026-06-10
04049016151296FITC-labelled Avidin (biotin affine)EUROIMMUN Medizinische Labordiagnostika AGPPM2026-06-10
04049016151630FITC-labelled anti-human IgG (primate absorbed)EUROIMMUN Medizinische Labordiagnostika AGPPM2026-06-10
08430793040839Aptiva® APS IgA CalibratorsINOVA DIAGNOSTICS, INC.JIX2026-06-10
00846405014194Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-09
00846405023417Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-09
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