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Seeker™

FDA UDI

Class I (US FDA UDI)

by Baebies Inc.

Identity

Trade Name
SEEKER™ FDA UDI
Generic Name
Multichannel clinical chemistry analyser IVD, laboratory FDA UDI
Device Name
The SEEKER™ Instrument is a quantitative in vitro diagnostic instrument for the determination of clinical chemistry analytes. FDA UDI
Model / Reference
2188 FDA UDI
Description
The SEEKER™ Instrument is a quantitative in vitro diagnostic instrument for the determination of clinical chemistry analytes. FDA UDI

Identifiers

Catalog Number
2188 FDA UDI
Primary DI / UDI-DI
00819704020197 FDA UDI
FDA Product Code
KHO FDA UDI
GMDN Term
Multichannel clinical chemistry analyser IVD, laboratory FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.2560 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

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Multichannel clinical chemistry analyser IVD, laboratory

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

Similar devices

Also classified as Multichannel clinical chemistry analyser IVD, laboratory.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Baebies Inc.

Sources (1)

  • FDA UDI 95437997-0e85-4890-acd1-a38f8978a30a 35 fields · synced May 31, 2026