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Baebies Extraction Solution

FDA UDI

Class I (US FDA UDI)

by Baebies Inc.

Identity

Trade Name
Baebies Extraction Solution FDA UDI
Generic Name
Newborn metabolic screen/congenital disorder IVD, reagent FDA UDI
Device Name
Baebies Extraction Solution General Purpose Reagent, For Laboratory Use FDA UDI
Model / Reference
2114 FDA UDI
Description
Baebies Extraction Solution General Purpose Reagent, For Laboratory Use FDA UDI

Identifiers

Catalog Number
3726 FDA UDI
Primary DI / UDI-DI
00819704020296 FDA UDI
FDA Product Code
PPM FDA UDI
GMDN Term
Newborn metabolic screen/congenital disorder IVD, reagent FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.4010 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

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, reagent

Baebies Extraction Solution 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, reagent.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Baebies Inc.

Sources (1)

  • FDA UDI 1ae8a74a-4460-486c-a688-e92e871370cd 36 fields · synced Jun 1, 2026