FDA.reportPublic FDA data

Access SHBG QC

Primary DI
15099590204051
Brand
Access SHBG QC
Company
Beckman Coulter, Inc.
Model
A48619
Catalog number
A48619
Device description
The Access SHBG QC is intended for monitoring system performance of the Access SHBG assay.
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

Product Codes#

Code, Name table
CodeName
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15099590204051PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959020405115099590204051

GMDN Terms#

Term, Definition table
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 table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15099590806255ACCESS HBsAgD229132026-01-16
15099590806262ACCESS HBsAg ConfirmatoryD229142026-01-16
15099590806279Access HBsAg CALIBRATORD229152026-01-16
15099590806286ACCESS HBsAg QCD229162026-01-16
15099590806415ACCESS anti-HAVD258312026-01-16
15099590806422ACCESS anti-HAV CALIBRATORD258322026-01-16
15099590806439ACCESS anti-HAV QCD258332026-01-16
15099590799717MicroScanV5.03D238242025-12-17
15099590799724MicroScanV5.03D238252025-12-17
15099590799755MicroScanV5.03D238282025-12-17
15099590799762MicroScanV5.03D238292025-12-17
05099590798973MicroScanD18443D184432025-12-08
05099590798980MicroScanD18444D184442025-12-08
05099590798997MicroScanD184452025-12-08
05099590799000MicroScanD184462025-12-08
05099590799017MicroScanD184472025-12-08
05099590799024MicroScanD184482025-12-08
15099590799243MicroScanV5.03 PU11ED233522025-12-08
15099590799250MicroScanV5.03 PU11D233542025-12-08
15099590807146MicroScanV5.03 DD07ED336042025-12-08

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