FDA.reportPublic FDA data

Synermed®

Primary DI
05060500091903
Brand
Synermed®
Company
INFRARED LABORATORY SYSTEMS LLC
Model
IR320-1200
Catalog number
IR320-1200
Device description
Serum Iron Reagent 2 X 67 mL + 1 X 44 mL
Published
2017-02-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CFMBathophenanthroline, Colorimetry, Iron (Non-Heme)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CFMBathophenanthroline, Colorimetry, Iron (Non-Heme)Clinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K912912000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K912912000SYNERMED SERUM IRON-600 REAGENT KITSynermed, Inc.1991-07-30CFM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060500091903PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060500091903050605000919035060500091903

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 Temperature0 Degrees Celsius4 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
317 896-1565info@irlabsystems.com

Regulatory Flags#

DUNS number
014210494
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060500090029Synermed®IR010-RIR010-R2016-09-20
05060500090036Synermed®IR010-XIR010-X2016-09-20
05060500090043Synermed®IR010-WKIR010-WK2016-09-20
05060500090050Synermed®IR010-911IR010-9112016-09-20
05060500090067Synermed®IR010-LIR010-L2016-09-20
05060500091682Synermed®IR010-1200IR010-12002017-02-28
05060500090739Synermed®VI560-RVI560-R2016-09-20
05060500090746Synermed®VI5600-XVI5600-X2016-09-20
05060500090753Synermed®VI560-WKVI560-WK2016-09-20
05060500090760Synermed®VI560-911VI560-9112016-09-20
05060500090777Synermed®VI561-LVI561-L2016-09-20
05060500090784Synermed®VI562-LVI562-L2016-09-20
05060500091873Synermed®VI560-1200VI560-12002017-02-28
05060500090005Synermed®IR-500IR-5002016-09-20
05060500090012Synermed®IR-1200IR-12002016-12-12
05060500091538Synermed®IR954IR9542016-09-20
05060500091545Synermed®IR961-XIR961-X2016-09-20
05060500091552Synermed®IR962-XIR962-X2016-09-20
05060500091590Synermed®ISE530-KISE530-K2016-09-20
05060500091613Synermed®0010012016-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060500090982Synermed®INFRARED LABORATORY SYSTEMS LLCCFM2016-09-20
05060500090999Synermed®INFRARED LABORATORY SYSTEMS LLCCFM2016-09-20
05060500091002Synermed®INFRARED LABORATORY SYSTEMS LLCCFM2016-09-20
05060500091019Synermed®INFRARED LABORATORY SYSTEMS LLCCFM2016-09-20
05060500091026Synermed®INFRARED LABORATORY SYSTEMS LLCCFM2016-09-20
05060500091033Synermed®INFRARED LABORATORY SYSTEMS LLCCFM2016-09-20