FDA.reportPublic FDA data

TfR

Primary DI
08600000686031
Brand
TfR
Company
Ramco Laboratories, Inc.
Model
TFC-94
Catalog number
TFC-94
Device description
ELISA- TfR
Published
2019-03-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JNMIMMUNOCHEMICAL, TRANSFERRIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JNMImmunochemical, TransferrinImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K981208000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K981208000TFRRamco Laboratories, Inc.1998-10-21JNM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08600000686031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08600000686031086000006860318600000686031

GMDN Terms#

Term, Definition table
TermDefinition
Soluble transferrin receptor IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the quantitative measurement of soluble transferrin receptor protein in a clinical specimen, using an enzyme immunoassay (EIA) method.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(281)313-1200ramcolab@aol.com

Regulatory Flags#

DUNS number
082013897
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18600000686021Cand-TecCO3/1CO3/12019-03-26
28600000686028Cand-TecCO3/2CO3/22019-03-26
78600000686023Cand-TecCO3/7CO3/72019-03-26
08600000686024Cand-TecCO3/5CO3/52019-03-23
08600000686048VFEVE-98VE-982019-03-26
08600000686017Spectro Ferritin MTS-22S-222019-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414596297Atellica CH TrfSiemens Healthcare Diagnostics Inc.JNM2017-12-22
00630414517711ADVIA® Chemistry TRF Transferrin ReagentsSiemens Healthcare Diagnostics Inc.JNM2016-09-24
00815762021657Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.JNM2016-07-29