ISBT 128: More than Identification
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ISBT 128 License Fees

 

Blood Facilities

Registration Fee: One-time payment of US$200 which includes allocation of the first Facility Identification Number (FIN).  Additional FINs can be requested at US$150 each.

Annual License Fee: This fee is based on the total number of Donation Identification Numbers (DINs) assigned in the previous year.  DINs are assigned to each collection or pooling event.

 

IF

Then

Your facility does not assign DINs or assigns <1000 DINs per year

Your annual license fee is US$150*

Your facility assigns between 1,000 and 14,228 DINs per year

Your annual license fee is US$175*

Your facility assigns >14,228 DINs per year

Your annual license fee will be US$.0123 times the number of collections per year.* 

For example, you collect 100,000 units per year.  100,000 * .0123 = US$1,230 per year.

* These fees are reduced for facilities that are located in countries with a Human Development Index (HDI) classification of Medium or Low.  For facilities in Medium HDI countries fees are 66% of the above figures.  For facilities in Low HDI countries fees are 33% of the above figures. Click here for more information about HDI

 

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Tissue Facilities

Registration Fee: One-time payment of US$200 which includes allocation of the first Facility Identification Number (FIN).  Additional FINs can be requested at US$150 each.

Annual License Fee: This fee is based on the number of final labeled tissue products produced in the previous year.

 

IF

Then

Your facility does not label final tissue products but does use ISBT 128 bar codes on procurement or in-process tissue products

Your annual license fee is US$300*

Your facility labels 2,000 final products a year

Your annual license fee is US$300*

Your facility labels >2,000 final products a year

Your annual license fee will be US US$0.15 times the number of labeled products per year.*

For example, you label 5,000 products per year.  5,000 * 0.15 = US$750 per year.

* These fees are reduced for facilities that are located in countries with a Human Development Index (HDI) classification of Medium or Low.  For facilities in Medium HDI countries fees are 66% of the above figures.  For facilities in Low HDI countries fees are 33% of the above figures. Click here for more information about HDI

 

 

Cellular Therapy Facilities

Registration Fee: One-time payment of US$200 which includes allocation of the first Facility Identification Number (FIN).  Additional FINs can be requested at US$150 each. 

Annual License Fee: Based on the total number of Donation Identification Numbers (DINs) assigned in the previous year.  DINs are assigned to each collection or pooling event.

 

IF

Then

Your facility does not assign DINs or assigns <14,228 per year

Your annual license fee is US$175*

Your facility assigns ≥14,228 DINs per year

Your annual license fee will be US$.0123 times the number of collections per year.*

For example, you collect 20,000 units per year.  20,000 * .0123 = US$246.00 per year.

 

*These fees are reduced for facilities that are located in countries with a Human Development Index (HDI) classification of Medium or Low.  For facilities in Medium HDI countries fees are 66% of the above figures.  For facilities in Low HDI countries fees are 33% of the above figures. Click here for more information about HDI


 

Plasma Fractionation Facilities

Registration fee:  See table below

Licensing fee:  The fee is based on the type of activity and volume in the previous year.  A fractionation facility carrying out several activities will need to pay the fee associated with each activity. 

IF

Registration Fee

Licensing Fee

Your facility reads ISBT 128 codes on plasma, whether originating from your own collection facilities or from a third party supplier.

None

Your annual licensing fee is US$5,250*

Your facility uses ISBT 128 identifiers on plasma collected.  You collect 14,228 units a year.

One-time payment of US$200 which includes allocation of the first Facility Identification Number (FIN).  Additional FINs can be requested at US$150 each.

Your annual license fee is US$175*

Your facility uses ISBT 128 identifiers on plasma collected.    You collect >14,228 units a year.

One-time payment of US$200 which includes allocation of the first Facility Identification Number (FIN).  Additional FINs can be requested at US$150 each.

Your annual license fee will be US$.0123 times the number of collections per year (e.g., you collect 100,000 units per year.  100,000 * .0123 = US$1,230 per year)

Your facility uses ISBT 128 on final product.  You label 14,228 products per year.

None

Your annual license fee is US$175)

Your facility uses ISBT 128 on final product.  You label >14,228 products per year.

None

For solvent detergent plasma products the fee is US$0.0123 per unit (US$1.23 per 100 units), with a minimum license fee of US$175.  For other plasma derivatives the fee has not yet been determined (contact the ICCBBA office for more information).*

*These fees are reduced for facilities that are located in countries with a Human Development Index (HDI) classification of Medium or Low.  For facilities in Medium HDI countries fees are 66% of the above figures.  For facilities in Low HDI countries fees are 33% of the above figures. Click here for more information about HDI.


Software Vendors

Registration Fee: None

Annual License Fee: The fee is based on the number of customers your company serves.

IF

Then

You supply software to a single customer

Your annual license fee is US$1,100

You supply software to 2-9 customers

Your annual license fee is US$2,750

You supply software ≥10 customers

Your annual license fee is US$5,250

 

Label Vendors

Registration Fee: None

Annual License Fee: The fee is based on type of activity and the volume in the previous year.

IF

Then

You sell ≤1,000,000 preprinted labels per year and do NOT supply associated software or hardware

Your annual license fee is US$2,750 per year.  To qualify for the reduced fee the vendor must submit a declaration of the number of ISBT 128 labels sold in the prior year.

You sell >1,000,000 preprinted labels per year and/or supply associated software or hardware

Your annual license fee is US$5,250 per year.

 

Other Vendors

Registration Fee: None

Annual License Fee: US$5,250