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Seeker™

FDA UDI

Class I (US FDA UDI)

by Baebies Inc.

Identity

Trade Name
SEEKER™ FDA UDI
Generic Name
Newborn metabolic screen/congenital disorder IVD, control FDA UDI
Device Name
SEEKER™ Quality Control Dried Blood Spot Kit Contains 5 levels: QC Base Pool, QC Low, QC Intermediate, QC Medium, and QC High FDA UDI
Model / Reference
3416 FDA UDI
Description
SEEKER™ Quality Control Dried Blood Spot Kit Contains 5 levels: QC Base Pool, QC Low, QC Intermediate, QC Medium, and QC High FDA UDI

Identifiers

Catalog Number
3416 FDA UDI
Primary DI / UDI-DI
00819704020227 FDA UDI
510(k) Number
DEN150035 FDA UDI
FDA Product Code
JJY FDA UDI
GMDN Term
Newborn metabolic screen/congenital disorder IVD, control FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1660 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Newborn metabolic screen/congenital disorder IVD, control

Seeker™ by Baebies Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Newborn metabolic screen/congenital disorder IVD, control.

Cleared under the same submission

DEN150035 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Baebies Inc.

Sources (1)

  • FDA UDI 5adb588e-85d5-4cc4-94d2-986785847bf0 37 fields · synced May 30, 2026