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Glycated Serum Protein Linearity Set

FDA UDI

Class I (US FDA UDI)

by Stanbio Laboratory, L.p.

Identity

Trade Name
Glycated Serum Protein Linearity Set FDA UDI
Generic Name
Fructosamine IVD, control FDA UDI
Device Name
Stanbio Glycated Serum Protein (GSP) Linearity Set is intended to be used for quality control procedures in verifying the linearity throughout the reportable range of Stanbio’s Glycated Serum Protein (GSP) LiquiColor®. For in-vitro diagnostic use only. FDA UDI
Model / Reference
2380-201 FDA UDI
Description
Stanbio Glycated Serum Protein (GSP) Linearity Set is intended to be used for quality control procedures in verifying the linearity throughout the reportable range of Stanbio’s Glycated Serum Protein (GSP) LiquiColor®. For in-vitro diagnostic use only. FDA UDI

Identifiers

Catalog Number
2380-201 FDA UDI
Primary DI / UDI-DI
00657498001134 FDA UDI
FDA Product Code
JJX FDA UDI
GMDN Term
Fructosamine IVD, control FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1660 FDA UDI
Commercial Distribution
Not 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Glycated Serum Protein Linearity Set by Stanbio Laboratory, L.p. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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 9c8138e4-7a40-443d-b1ae-f7b39e0c3d25 37 fields · synced May 30, 2026