FDA.reportPublic FDA data

Teco Diagnostics Urine Porphobilinogen (PBG) Test Kit

Primary DI
10673486001006
Brand
Teco Diagnostics Urine Porphobilinogen (PBG) Test Kit
Company
TECO DIAGNOSTICS
Model
URS-PBG-1
Catalog number
URS-PBG-1
Device 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.
Published
2023-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JNFIon-Exchange Resin, Ehrlich'S Reagent, Porphobilinogen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JNFIon-Exchange Resin, Ehrlich'S Reagent, PorphobilinogenClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10673486001006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1067348600100610673486001006

GMDN Terms#

Term, Definition table
TermDefinition
Porphobilinogen IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of the porphyrin metabolite porphobilinogen in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
7144631111hello@tecodiagnostics.com

Regulatory Flags#

DUNS number
185067774
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10673486014068Teco Diagnostics Infectious Mononucleosis (IM) Latex TestIML-50IML-502026-05-21
10673486014051Teco Diagnostics Anti-Streptolysin O (ASO) Reagent SetASO-50ASO-502026-05-07
10673486014037Teco Diagnostics Creatinine (Kinetic) Reagent Kit for TC-Matrix-240C514-650TC2C514-650TC22026-04-30
10673486014044Teco Diagnostics Creatinine (Kinetic) Reagent Kit for TC-Matrix-480C514-650TC4C514-650TC42026-04-30
10673486014020Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Dipstick TestP597-25P597-252026-04-09
10673486014013Teco Diagnostics Chemistry CalibratorTC-CAL-MULTITC-CAL-MULTI2026-03-20
10673486014006Teco Diagnostics One-Step Pregnancy Dipstick TestP595-AP595-A2026-02-12
10673486013993Teco Diagnostics Rapid Fecal Occult Blood (FOB) TestF735-25F735-252026-01-30
10673486013986Teco Diagnostics H. Pylori Card TestH730-50H730-502026-01-27
10673486013979Teco Diagnostics ALT (SGPT) Reagent Set (Colorimetric, Endpoint Method)A526-120A526-1202026-01-19
10673486001013Albumin Reagent SetA502-480A502-4802023-07-07
10673486001020Albumin -BCG method TC-MatrixA502-510TMA502-510TM2023-07-07
10673486002478GLUCOPAD TC-SMART+ Lancets KitG852-E-001G852-E-0012025-06-10
10673486002461GLUCOPAD TC-SMART+ Lancets KitG852-E-001G852-E-0012025-05-14
10673486013580Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTC-MatrixTC-Matrix2025-05-28
10673486013726Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTC-MATRIX-160TC-MATRIX-1602025-05-28
10673486013894Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTC-Matrix-240TC-Matrix-2402025-05-28
10673486013962Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTC-Matrix-480TC-Matrix-4802025-05-28
10673486000726Teco Diagnostics Glucopad Blood Glucose Test StripsGlucopad Blood Glucose Test StripsG852-B-0022024-12-19
10673486002454Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Card TestP596-25P596-252024-12-19