FDA.reportPublic FDA data

Access Inhibin A Calibrators

Primary DI
15099590203054
Brand
Access Inhibin A Calibrators
Company
Beckman Coulter, Inc.
Model
A36098
Catalog number
A36098
Device description
The Access Inhibin A Calibrators are intended to calibrate the Access Inhibin A assay for the quantitative determination of dimeric inhibin A levels i
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
JITCalibrator, Secondary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JITCalibrator, SecondaryClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15099590203054PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959020305415099590203054

GMDN Terms#

Term, Definition table
TermDefinition
Inhibin A IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the quantitative measurement of inhibin A in a clinical specimen, using an enzyme immunoassay (EIA) 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

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15099590799762MicroScanV5.03D238292025-12-17
05099590798973MicroScanD18443D184432025-12-08
05099590798980MicroScanD18444D184442025-12-08
05099590798997MicroScanD184452025-12-08
05099590799000MicroScanD184462025-12-08
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15099590799250MicroScanV5.03 PU11D233542025-12-08
15099590807146MicroScanV5.03 DD07ED336042025-12-08

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