FDA.reportPublic FDA data

Ostase®+ BAP EIA

Primary DI
05060169690059
Brand
Ostase®+ BAP EIA
Company
IMMUNODIAGNOSTIC SYSTEMS LIMITED
Model
AC-20F1
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
CINElectrophoretic Separation, Alkaline Phosphatase Isoenzymes

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CINElectrophoretic Separation, Alkaline Phosphatase IsoenzymesClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K972666000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K972666000TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAYHybritech, Inc.1997-09-11CIN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060169690059PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060169690059050601696900595060169690059

GMDN Terms#

Term, Definition table
TermDefinition
Bone alkaline phosphatase (BALP) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement of bone alkaline phosphatase (BALP) 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
05060169695801IDS-iSYS Ostase® BAPIMMUNODIAGNOSTIC SYSTEMS LIMITEDCIN2021-03-08
30014613333920MicroVueQUIDEL CORPORATIONCIN2016-09-15
15099590232313Access OstaseBeckman Coulter, Inc.CIN2016-09-09
M52530580TITAN GEL Alkaline Phosphatase KitHELENA LABORATORIES CORPORATIONCIN2016-09-07
M52533480SPIFE ALP Separation EnhancerHELENA LABORATORIES CORPORATIONCIN2016-09-07
M52551020Alkaline Phosphatase Indolyl Blue Reagent KitHELENA LABORATORIES CORPORATIONCIN2016-09-07
M5255510310TITAN GEL Alkaline Phosphatase Reagent KitHELENA LABORATORIES CORPORATIONCIN2016-09-07
M5255520550SPIFE Alkaline Phosphatase Reagent KitHELENA LABORATORIES CORPORATIONCIN2016-09-07
M5255523950SPIFE Alkaline Phosphatase-20,40 Gel KitHELENA LABORATORIES CORPORATIONCIN2016-09-07
M5255526040SPIFE Alkaline Phosphatase Gel KitHELENA LABORATORIES CORPORATIONCIN2016-09-07
06438115000082UniQ® PINP RIAAidian OyCIN2016-04-13