FDA.reportPublic FDA data

Teco Diagnostics Iron/TIBC Reagent Set

Primary DI
10673486001983
Brand
Teco Diagnostics Iron/TIBC Reagent Set
Company
TECO DIAGNOSTICS
Model
I592-100
Catalog number
I592-100
Device description
Teco Diagnostics Iron/TIBC Reagent Set is used for the quantitative determination of iron, total iron-binding capacity in human serum.
Published
2023-11-13
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
JIYPhotometric Method, Iron (Non-Heme)
JMOFerrozine (Colorimetric) Iron Binding Capacity

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JIYPhotometric Method, Iron (Non-Heme)Clinical Chemistry1
JMOFerrozine (Colorimetric) Iron Binding CapacityClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K901561000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K901561000IRON/TOTAL IRON BINDING CAPACITYTech-Co, Inc.1990-05-17JIY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10673486001983PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1067348600198310673486001983

GMDN Terms#

Term, Definition table
TermDefinition
Iron 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 quantitative measurement of iron in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
7144631111hello@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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10673486000726Teco Diagnostics Glucopad Blood Glucose Test StripsGlucopad Blood Glucose Test StripsG852-B-0022024-12-19
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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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