FDA.reportPublic FDA data

Teco Diagnostics Phosphorus Reagent Kit (UV Method) TC Matrix

Primary DI
10673486001976
Brand
Teco Diagnostics Phosphorus Reagent Kit (UV Method) TC Matrix
Company
TECO DIAGNOSTICS
Model
I516-780TM
Catalog number
I516-780TM
Device description
Teco Diagnostics Phosphorus Reagent Kit (UV Method) TC Matrix is used for the quantitative determination of inorganic phosphorus in serum or plasma on TC Matrix analyzers.
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
CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CEOPhosphomolybdate (Colorimetric), Inorganic PhosphorusClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K881171000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K881171000PHOSPHORUS (INORGANIC)Tech-Co, Inc.1988-04-28CEO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10673486001976PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1067348600197610673486001976

GMDN Terms#

Term, Definition table
TermDefinition
Inorganic phosphate (PO43-) 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 inorganic phosphate (PO43-) [phosphorus] 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
Kit
true
Lot or batch
true
Expiration date on label
true

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