FDA.report

Dimension® EXL™ LOCI® Module Flex® reagent cartridge FT3

Primary DI
00842768032622
Brand
Dimension® EXL™ LOCI® Module Flex® reagent cartridge FT3
Company
Siemens Healthcare Diagnostics Inc.
Model
10483414
Catalog number
RF616
Device description
LOCI Free Triiodothyronine Flex® reagent cartridge, 120 tests
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
CDPRADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE

Product Code Classifications

CodeDeviceSpecialtyClass
CDPRadioimmunoassay, Total TriiodothyronineClinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842768032622PrimaryGS10
00630414005782Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768032622008427680326228427680326220842768032622
00630414005782006304140057826304140057820630414005782

GMDN Terms

TermDefinition
Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement of free triiodothyronine (FT3) in a clinical specimen, using a chemiluminescent immunoassay method.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)441-9250XX@XX.XX
+1(800)441-9250CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags

DUNS number
005088112
Device count
4
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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