FDA.report

Elecsys DHEA-S

Primary DI
04015630917372
Brand
Elecsys DHEA-S
Company
Roche Diagnostics GmbH
Model
3000087122
Catalog number
3000087122
Published
2021-01-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
JKCRADIOIMMUNOASSAY, DEHYDROEPIANDROSTERONE (FREE AND SULFATE)

Product Code Classifications

CodeDeviceSpecialtyClass
JKCRadioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)Clinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04015630917372PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04015630917372040156309173724015630917372

GMDN Terms

TermDefinition
Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement of dehydroepiandrosterone sulfate (DHEAS) in a clinical specimen, using a chemiluminescent immunoassay method.

Sterilization Methods

Method

Regulatory Flags

DUNS number
315028860
Device count
1
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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