Appropriate use of the REF symbol in IVD kits and kit components

M

MPiska

#1
Hi All,

As per the definitions in EN980 and ISO15223-1 the REF symbol is the Manufacturers Catalogue Number (aka reference number or re-order number)

We have reagents that are not sold separately, but form a part of multiple kits,as such each component does not have its own catalogue number.

On these reagents we currently include the REF symbol and then list all catalogue numbers of the kits that this reagent is present in - is this considered appropriate use of the REF symbol?

Thanks,

MP.
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Moderator
#2
Hi All,

As per the definitions in EN980 and ISO15223-1 the REF symbol is the Manufacturers Catalogue Number (aka reference number or re-order number)

We have reagents that are not sold separately, but form a part of multiple kits,as such each component does not have its own catalogue number.

On these reagents we currently include the REF symbol and then list all catalogue numbers of the kits that this reagent is present in - is this considered appropriate use of the REF symbol?

Thanks,

MP.
Hi,

If the reagent is not offered for sale separately it should bear your own internal cat number for it. I assume you have one for process control purposes.

Cheers,
Ronen.
 
M

MPiska

#3
Thank you, Ronen.

We use that method for several of our older products, where they are sold as a separate accessory item and as a part of a kit.

i.e
filled reagent bottle is REF XX01
The code is not the full internal REF that we use but forms a unique part of it.

Packed kit that includes reagent is REF Z1111111
Packed reagent on own as a single accessory is REF Z222222


On some of the newer kits that we have acquired due to purchases the filled reagent in this example would state REF Z1111111, Z222222


I have questioned this and been told it is acceptable but I was still not sure, hence this thread. Thank you for confirming my own beliefs.

It would be good to have some more comments before I take this back to my boss for further discussion.
 
Thread starter Similar threads Forum Replies Date
B What are "appropriate drawings" required for a MDR in 21CFR820? ISO 13485:2016 - Medical Device Quality Management Systems 4
C What is the Appropriate AQL for Purchased Implantable Devices? Supplier Quality Assurance and other Supplier Issues 5
N ISO 19011:2018 - 5.4.2 "...audit program should engage in appropriate continual development..." Training - Internal, External, Online and Distance Learning 4
A ISO 13485 - Clause 8.3.3 appropriate actions in response to nonconforming product ISO 13485:2016 - Medical Device Quality Management Systems 2
E What are appropriate deviations for a LHR/DHR? (Medical Device Company) Manufacturing and Related Processes 3
S When is ISO 13485:2016 6.4.2 Contamination Control appropriate? ISO 13485:2016 - Medical Device Quality Management Systems 11
C ICP versus AA: How to determine appropriate specification for assay method verification Qualification and Validation (including 21 CFR Part 11) 1
K Please help identify appropriate statistical treatment Statistical Analysis Tools, Techniques and SPC 13
A Electric terminal crimping machines - Is SPC appropriate for this process? Manufacturing and Related Processes 4
Le Chiffre Is ISO/IEC 27001 appropriate for most small businesses? IEC 27001 - Information Security Management Systems (ISMS) 2
W EU GMP Annex XI - What is an "appropriate QMS"? Other Medical Device Related Standards 2
F Appropriate Control Chart Statistical Analysis Tools, Techniques and SPC 5
N Taking exception to REACH Requirement - Appropriate Language REACH and RoHS Conversations 4
Q When does the FDA deem something "where appropriate"? 21CFR820.30(g) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
Y "As appropriate" in ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 20
S What is appropriate PPM level for a Plastic Injection Moulding Supplier Quality Tools, Improvement and Analysis 4
D What is the appropriate way to write a conclusion from a % contribution result? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
R Why customer satisfaction is not appropriate regulatory objective in medical device? ISO 13485:2016 - Medical Device Quality Management Systems 8
C What is the most appropriate Bioburden Test Method for Surgical Gloves ISO 13485:2016 - Medical Device Quality Management Systems 10
Q Writing appropriate ISO 13485 Audit Report Findings Internal Auditing 15
J Lean Appropriate KPIs for a Distribution Centre Lean in Manufacturing and Service Industries 1
I Is ARIMA (Time Series Analysis) Model appropriate for this Dental Research? Using Minitab Software 4
L Most appropriate Auditor to check the FMEA & PCP of a Manufacturing Process IATF 16949 - Automotive Quality Systems Standard 5
J Appropriate In-Process Monitoring Frequency for 2X per day Change Set-Up. Statistical Analysis Tools, Techniques and SPC 3
C Appropriate ways to address Competency? Generic vs Specific ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
somashekar What is D&D Output for appropriate information for Production? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
M 8.2.4.2 Appearance Items - When Masters for Colour, Grain, etc are not appropriate? IATF 16949 - Automotive Quality Systems Standard 6
D General Guideline for an appropriate Sample Size for measuring Cp and Cpk Capability, Accuracy and Stability - Processes, Machines, etc. 11
D Appropriate Statistical Methods to set up an Alert/Warning Limit Quality Assurance and Compliance Software Tools and Solutions 15
B What is the Appropriate Sample Size for a Customer Survey? Customer Complaints 5
J The appropriate Attribute MSA for Automatic Visual Inspection Machine Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
J Appropriate Test Environments for In-Glass Liquid Thermometer Calibrations General Measurement Device and Calibration Topics 2
R How to select appropriate standards for Multi-Functional Physical Therapy Equipment IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
T Appropriate Lean Six Sigma Green Belt Project Proposal? Six Sigma 10
I ASQ CQT Exam - Appropriate study time and best resources recommendations Professional Certifications and Degrees 8
T Determining the appropriate Sample Size using an AQL Table Inspection, Prints (Drawings), Testing, Sampling and Related Topics 31
B Appropriate Standards for Food Packaging Adhesive Manufacture Food Safety - ISO 22000, HACCP (21 CFR 120) 7
O Can anyone recommend appropriate standard for Reliability Testing of Cables Other Medical Device Related Standards 3
C What is the most appropriate MSA (Measurement System Analysis) Study Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
C What is the appropriate DPPM for to be used In-Process Inspection Other Medical Device Related Standards 2
S Pp/Ppk & Cp/Cpk - Which is appropriate for Long/Short Term Study? Statistical Analysis Tools, Techniques and SPC 20
J Ethics Training and Policy appropriate for an ISO 17025 Testing Laboratory ISO 17025 related Discussions 4
K Recommendations for an appropriate Recorder used at low temperature (Below 500?F) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
M z Test vs. F Test - The most appropriate for comparing the Variances Statistical Analysis Tools, Techniques and SPC 3
B Appropriate ISO Clauses reference in Procedure Manual ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
C Starting an MSA study - How to decide which is appropriate or required Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
somashekar Hazardous Waste: Is this an appropriate interpretation Miscellaneous Environmental Standards and EMS Related Discussions 1
G Appropriate Processes for Information Security Management System (ISMS) IEC 27001 - Information Security Management Systems (ISMS) 7
N Which is more appropriate Regular or Short Run control charting? Statistical Analysis Tools, Techniques and SPC 8
M Two situations where it is appropriate to add further Hazard Audits to Internal Audit Occupational Health & Safety Management Standards 8

Similar threads

Top Bottom