← Back to catalogue

BG Analytics Software

FDA UDI

Class I (US FDA UDI)

by Associates Of Cape Cod, Inc.

Identity

Trade Name
BG Analytics Software FDA UDI
Generic Name
Laboratory instrument/analyser application software IVD FDA UDI
Device Name
a calculator/data processing module for clinical use described as electronic device intended to store, retrieve, and process laboratory data. FDA UDI
Model / Reference
0 FDA UDI
Description
a calculator/data processing module for clinical use described as electronic device intended to store, retrieve, and process laboratory data. FDA UDI

Identifiers

Primary DI / UDI-DI
00862696000289 FDA UDI
FDA Product Code
JQP FDA UDI
GMDN Term
Laboratory instrument/analyser application software IVD FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.2100 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

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Laboratory instrument/analyser application software IVD

BG Analytics Software by Associates Of Cape Cod, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Laboratory instrument/analyser application software IVD.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Associates Of Cape Cod, Inc.

Sources (1)

  • FDA UDI 0746e3aa-eaf3-4b62-9741-0043f9744e59 33 fields · synced Jun 8, 2026