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Teco Diagnostics Urea Nitrogen (BUN) Reagent Set (Colorimetric Method)

Primary DI
10673486001266
Brand
Teco Diagnostics Urea Nitrogen (BUN) Reagent Set (Colorimetric Method)
Company
TECO DIAGNOSTICS
Model
B551-66
Catalog number
B551-66
Device description
Teco Diagnostics Urea Nitrogen (BUN) Reagent Set (Colorimetric Method) is used for the direct colorimetric determination of Urea Nitrogen (BUN) in human serum or plasma.
Published
2023-07-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CDLBerthelot Indophenol, Urea Nitrogen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CDLBerthelot Indophenol, Urea NitrogenClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K864742000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K864742000UREA NITROGEN(BUN), COLORIMETRIC METHODTech-Co, Inc.1987-01-13CDL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10673486001266PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1067348600126610673486001266

GMDN Terms#

Term, Definition table
TermDefinition
Urea 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 urea or urea nitrogen [also known as blood urea nitrogen (BUN)] 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
714-463-1111hello@tecodiagnostics.com

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
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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
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10673486013993Teco Diagnostics Rapid Fecal Occult Blood (FOB) TestF735-25F735-252026-01-30
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10673486002478GLUCOPAD TC-SMART+ Lancets KitG852-E-001G852-E-0012025-06-10
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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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10673486001273Teco Diagnostics Urea Nitrogen (BUN) Reagent Set (Colorimetric Method)TECO DIAGNOSTICSCDL2023-07-21
00811727010568POINTE SCIENTIFIC BUN (Berthelot)HORIBA INSTRUMENTS INCORPORATEDCDL2016-08-31