FDA.reportPublic FDA data

ACP

Primary DI
05055273200065
Brand
ACP
Company
RANDOX LABORATORIES LIMITED
Model
AC1011
Catalog number
AC1011
Device description
The acid phosphatase test system is intended for the quantitative in vitro determination of Acid Phosphatase in serum.
Published
2016-09-09
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
CKBAcid Phosphatase, Naphthyl Phosphate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CKBAcid Phosphatase, Naphthyl PhosphateClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K023840000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K023840000ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650Bayer Diagnostics Corp.2003-01-07CKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055273200065PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055273200065050552732000655055273200065

GMDN Terms#

Term, Definition table
TermDefinition
Acid phosphatase isoenzyme IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of one or multiple acid phosphatase isoenzymes in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+442894451070technical.services@randox.com

Regulatory Flags#

DUNS number
227530649
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
05055273200560AMYAY1580AY15802016-09-09
05055273200577AMYAY1582AY15822016-09-09
05055273200584AMYAY2811AY28112016-09-09
05055273200591P AMYAY2862AY28622016-09-09
05055273200607AMYAY3805AY38052016-09-09
05055273200614P AMYAY3855AY38552016-09-09
05055273200645AMYAY7931AY79312016-09-09
05055273200652AMYAY7932AY79322016-09-09
05055273200669P AMYAY7934AY79342016-09-09
05055273200676AMYAY9707AY97072016-09-09
05055273220780BIOHACKER Premium Home Blood Sampling Collection KitSCK10754SCK107542026-05-22
05055273220797MALE HORMONE Premium Home Blood Sampling Collection KitSCK10755SCK107552026-05-22
05055273220803BASELINE Venous Sample Collection kitSCK10756SCK107562026-05-22
05055273220995FEMALE HORMONE Premium Home Blood Sampling Collection KitSCK10767SCK107672026-05-22
05055273221640BASELINE SELF-DRAW Premium Home Blood Sampling Collection KitSCK10796SCK107962026-05-22
05055273207620COAGULATION CONTROL - LEVEL 1 (COAG CONTROL 1)CG50212019-06-03
05055273207637COAGULATION CONTROL - LEVEL 2 (COAG CONTROL 2)CG50222019-06-03
05055273207644COAGULATION CONTROL - LEVEL 3 (COAG CONTROL 3)CG50232019-06-03
05055273208405COAGULATION CALIBRATOR (COAG CAL)CG50372019-06-03
05055273204476APOLIPOPROTEIN E (APO E)LP38642019-06-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10673486001198ACID PHOSPHATASE REAGENT SET (KINETIC METHOD)TECO DIAGNOSTICSCKB2023-07-20
00817302024241CAROLINA LIQUID CHEMISTRIES CORP.® GGT REAGENT KIT CC209CAROLINA LIQUID CHEMISTRIES CORPORATIONCKB2022-08-19
00817302024050CLC GAMMA-GLUTAMYL TRANSFERASE GGT REAGENT KIT AU-209CAROLINA LIQUID CHEMISTRIES CORPORATIONCKB2022-07-06
05055273208122ACID PHOSPHATASE (ACP)RANDOX LABORATORIES LIMITEDCKB2019-05-31
00380740019655ARCHITECTABBOTT LABORATORIESCKB2016-09-09