ACID PHOSPHATASE (ACP)

GUDID 05055273208122

RANDOX LABORATORIES LIMITED

Total acid phosphatase (TAP) IVD, kit, spectrophotometry Total acid phosphatase (TAP) IVD, kit, spectrophotometry Total acid phosphatase (TAP) IVD, kit, spectrophotometry Total acid phosphatase (TAP) IVD, kit, spectrophotometry Total acid phosphatase (TAP) IVD, kit, spectrophotometry Total acid phosphatase (TAP) IVD, kit, spectrophotometry Total acid phosphatase (TAP) IVD, kit, spectrophotometry Total acid phosphatase (TAP) IVD, kit, spectrophotometry Total acid phosphatase (TAP) IVD, kit, spectrophotometry Total acid phosphatase (TAP) IVD, kit, spectrophotometry Total acid phosphatase (TAP) IVD, kit, spectrophotometry Total acid phosphatase (TAP) IVD, kit, spectrophotometry Total acid phosphatase (TAP) IVD, kit, spectrophotometry Total acid phosphatase (TAP) IVD, kit, spectrophotometry 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

05055273219951 - ESSENTIAL PACKAGE SAMPLE COLLECTION KIT (USA) 2024-02-07 The Blood Sample Collection Kit is intended for use in the collection and transport of a blood sample, taken by a trained phlebo
05055273219968 - EXTENDED PACKAGE SAMPLE COLLECTION KIT (USA) 2024-02-07 The Blood Sample Collection Kit is intended for use in the collection and transport of a blood sample, taken by a trained phlebo
05055273219999 - EXTENDED PACKAGE SAMPLE COLLECTION KIT (USA U60)2024-02-07 The Blood Sample Collection Kit is intended for use in the collection and transport of a blood sample, taken by a trained phlebo
05055273218480 - BNP CONTROLS FOR BECKMAN (BNP CONTROL)2023-12-29 The BNP Controls for Beckman (CQ10520) are intended for use with in vitro diagnostic assays for the quantitative determination o
05055273218497 - BNP CONTROLS FOR ABBOTT (BNP CONTROL)2023-12-29 The BNP Controls for Abbott (CQ10521) are intended for use with in vitro diagnostic assays for the quantitative determination of
05055273218725 - XANTHOCHROMIA POSITIVE CONTROL (XANTHOCHROMIA )2023-12-29 The Xanthochromia Positive Control is intended for use with in vitro diagnostic assays for the quantitative determination of Bil
05055273218732 - XANTHOCHROMIA NEGATIVE CONTROL (XANTHOCHROMIA )2023-12-29 The Xanthochromia Negative Control is intended for use with in vitro diagnostic assays for the quantitative determination of Bil
05055273218992 - PRE-ECLAMPSIA CONTROL LEVEL 32023-12-29 The Pre eclampsia Control Level 3 is intended for use with in vitro diagnostic assays for the quantitative determination of plac

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.