FDA.report

Access SHBG

Primary DI
15099590204037
Brand
Access SHBG
Company
Beckman Coulter, Inc.
Model
A48617
Catalog number
A48617
Device description
The Access SHBG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Sex Hormone Binding Globulin leve
Published
2016-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
CDZRadioimmunoassay, Testosterones And Dihydrotestosterone

Product Code Classifications

CodeDeviceSpecialtyClass
CDZRadioimmunoassay, Testosterones And DihydrotestosteroneClinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
15099590204037PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1509959020403715099590204037

GMDN Terms

TermDefinition
Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement of sex hormone binding globulin (SHBG) in a clinical specimen, using a chemiluminescent immunoassay method.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008254708
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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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