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Excel® Chemistry Analyzer

FDA UDI

Class I (US FDA UDI)

by Stanbio Laboratory, L.p.

Identity

Trade Name
Excel® Chemistry Analyzer FDA UDI
Generic Name
Multiple clinical chemistry analyser IVD, laboratory, semi-automated FDA UDI
Device Name
This instrument is intended to be used to read and calculate the results of in-vitro clinical diagnostic assays, as well as any other application requiring absorbance or concentration readings at or near the available wavelengths. This general purpose instrument is intended to be used by laboratory professionals capable of selecting the appropriate features and options for each specific clinical application. FDA UDI
Model / Reference
G7700E-001 FDA UDI
Description
This instrument is intended to be used to read and calculate the results of in-vitro clinical diagnostic assays, as well as any other application requiring absorbance or concentration readings at or near the available wavelengths. This general purpose instrument is intended to be used by laboratory professionals capable of selecting the appropriate features and options for each specific clinical application. FDA UDI

Identifiers

Catalog Number
G7700E-001 FDA UDI
Primary DI / UDI-DI
00657498000380 FDA UDI
FDA Product Code
JJQ FDA UDI
GMDN Term
Multiple clinical chemistry analyser IVD, laboratory, semi-automated FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.2300 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

No

FDA UDI

Category: Multiple clinical chemistry analyser IVD, laboratory, semi-automated

Excel® Chemistry Analyzer by Stanbio Laboratory, L.p. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple clinical chemistry analyser IVD, laboratory, semi-automated.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Stanbio Laboratory, L.p.

Sources (1)

  • FDA UDI 99e8bac4-2814-4cd0-a309-9bff78a29c62 36 fields · synced May 30, 2026