ACID PHOSPHATASE (ACP)

GUDID 05055273208122

RANDOX LABORATORIES LIMITED

Total acid phosphatase (TAP) IVD, kit, spectrophotometry
Primary Device ID05055273208122
NIH Device Record Key49f77806-d60e-4b6e-902f-20daf9f77406
Commercial Distribution StatusIn Commercial Distribution
Brand NameACID PHOSPHATASE (ACP)
Version Model NumberAC8001
Company DUNS227530649
Company NameRANDOX LABORATORIES LIMITED
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105055273208122 [Primary]

FDA Product Code

CKBAcid Phosphatase, Naphthyl Phosphate

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-07-06
Device Publish Date2019-05-31

Devices Manufactured by RANDOX LABORATORIES LIMITED

05055273210101 - Liquid Immunoassay Control – Level 1 (IA CONTROL 1)2025-04-01 The Liquid Immunoassay Control is intended for use with in vitro diagnostic assays for the quantitative determination of 25-OH V
05055273210118 - LIQUID IMMUNOASSAY CONTROL - LEVEL 2 (IA CONTROL 2)2025-04-01 The Liquid Immunoassay Control is intended for use with in vitro diagnostic assays for the quantitative determination of 25-OH V
05055273210125 - LIQUID IMMUNOASSAY CONTROL - LEVEL 3 (IA CONTROL 3)2025-04-01 The Liquid Immunoassay Control is intended for use with in vitro diagnostic assays for the quantitative determination of 25-OH V
05055273219814 - PTH CONTROL LEVEL 1 (PTH CONTROL 1)2025-04-01 The PTH Control Level 1 is intended for use with in vitro diagnostic immunoassays for the quantitative determination of Parathyr
05055273219821 - PTH CONTROL LEVEL 2 (PTH CONTROL 2)2025-04-01 The PTH Control Level 2 is intended for use with in vitro diagnostic immunoassays for the quantitative determination of Parathyr
05055273219838 - PTH CONTROL LEVEL 3 (PTH CONTROL 3)2025-04-01 The PTH Control Level 3 is intended for use with in vitro diagnostic immunoassays for the quantitative determination of Parathyr
05055273219043 - LIQUID CARDIAC CONTROL 12025-03-31 The Liquid Cardiac Controls are intended for use with in vitro diagnostic assays for the quantitative determination of CKMB, Hig
05055273219050 - LIQUID CARDIAC CONTROL 22025-03-31 The Liquid Cardiac Controls are intended for use with in vitro diagnostic assays for the quantitative determination of CKMB, Hig

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