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Teco Diagnostics Urine Porphobilinogen (PBG) Test Kit

FDA UDI

Class I (US FDA UDI)

by Teco Diagnostics

Identity

Trade Name
Teco Diagnostics Urine Porphobilinogen (PBG) Test Kit FDA UDI
Generic Name
Porphobilinogen IVD, reagent FDA UDI
Device Name
Teco Diagnostics Urine Porphobilinogen (PBG) Test Kit is intended for the in vitro qualitative determination of porphobilinogen (PBG) in urine to aid in the primary screening for acute porphyria. For Professional Use only. FDA UDI
Model / Reference
URS-PBG-1 FDA UDI
Description
Teco Diagnostics Urine Porphobilinogen (PBG) Test Kit is intended for the in vitro qualitative determination of porphobilinogen (PBG) in urine to aid in the primary screening for acute porphyria. For Professional Use only. FDA UDI

Identifiers

Catalog Number
URS-PBG-1 FDA UDI
Primary DI / UDI-DI
10673486001006 FDA UDI
FDA Product Code
JNF FDA UDI
GMDN Term
Porphobilinogen IVD, reagent FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1590 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

Yes

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

No

FDA UDI

Category: Porphobilinogen IVD, reagent

Teco Diagnostics Urine Porphobilinogen (PBG) Test Kit by Teco Diagnostics — 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
Teco Diagnostics

Sources (1)

  • FDA UDI 717d06bc-29e3-4125-89fe-78f59a54d009 36 fields · synced May 30, 2026