FDA.reportPublic FDA data

N-MID® Osteocalcin ELISA

Primary DI
05060169690516
Brand
N-MID® Osteocalcin ELISA
Company
IMMUNODIAGNOSTIC SYSTEMS LIMITED
Model
AC-11F1
Published
2016-04-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NEOSystem, Test, Osteocalcin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NEOSystem, Test, OsteocalcinClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K003609000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K003609000N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000Osteometer Biotech A/S2001-05-16NEO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060169690516PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060169690516050601696905165060169690516

GMDN Terms#

Term, Definition table
TermDefinition
Osteocalcin IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement of osteocalcin in a clinical specimen, using a chemiluminescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius8 Degrees Celsius
Special Storage Condition, Specify00Store upon receipt at 2 to 8 degrees celsius
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4401915190660info.uk@idsplc.com

Regulatory Flags#

DUNS number
494268600
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060169690721IDS-iSYS Total TestosteroneN/AIS-50002026-04-17
05060169690875IDS-iSYS Total Testosterone Control SetN/AIS-50302026-04-17
05060169691063IDS-iSYS Total Testosterone Calibration VerifiersN/AIS-50352026-04-17
05060169691230IDS-iSYS Free TestosteroneIS-53002025-11-03
05060169691247IDS-iSYS Free Testosterone Control SetIS-53302025-11-03
05060169691254IDS-iSYS Free Testosterone Calibration VerifiersIS-53352025-11-03
05060169693968IDS-i10IS-8104002023-06-27
05060169691223IDS-iSYS Multi Discipline Automated SystemIS-3104002016-04-01
05060169695986IDS Beta CrossLaps® (CTX-I)IS-3000N2024-01-03
05060169696013IDS Beta CrossLaps® (CTX-I) Calibrator SetIS-3020N2024-01-03
05060169696051IDS Beta CrossLaps® (CTX-I) Control SetIS-3030N2024-01-03
05060169696457IDS ACTH IIIS-4500NG2023-08-23
05060169696495IDS ACTH II Calibrator SetIS-4520NG2023-08-23
05060169696532IDS ACTH II Control SetIS-4530NG2023-08-23
05060169691148IDS-iSYS SDSpeed CalcIS-SDSCALC2023-06-27
05060169691261IDS AndrostenedioneIS-54002023-06-27
05060169691278IDS Androstenedione Control SetIS-54302023-06-27
05060169692305IDS-iSYS D-Sorb SolutionIS-DS2002023-06-27
05060169693913IDS Top Cap SetIS-CAP3002023-06-27
05060169696099IDS Androstenedione Calibrator SetIS-54202023-06-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04015630940462Elecsys N-MID OsteocalcinRoche Diagnostics GmbHNEO2017-04-21
04015630939084Elecsys NMID Osteocalcin ImmunoassayRoche Diagnostics GmbHNEO2016-09-20