Proactively mitigate risk in IVD assay development and manufacturing with Diagnostic Elite

Invest in your future product security and proactively mitigate risk with fit-for-use critical raw materials.

The Diagnostic Elite Advantage

The Diagnostic Elite program provides key attributes that enable IVD manufacturers to minimize risk and increase consistency.

Diagnostic Elite Advantage

Development and manufacturing of IVD assays is a complex process involving:

  • Critical raw material requirements. Appropriate product selection is key to avoiding disruptions in assay design, delays in manufacturing, and impact on assay performance.
  • Evolving IVD industry regulations. Create a requirement for enhanced supplier support.

Cost vs. Severity

The Diagnostic Elite program was developed as an enhanced portfolio of raw materials with your IVD manufacturing needs in mind. Every Diagnostic Elite raw material is designed to promote consistency across your entire assay production process, with the goal of improving manufacturing effectiveness while minimizing your level of risk.

The Diagnostic Elite program leverages our knowledge of IVD industry regulations, manufacturing, quality and supply chain management to provide you with the required level of support to meet your IVD manufacturing requirements.

With a better understanding of the raw material attributes of Elite products, you can proactively choose products that best meet your current and future manufacturing needs.

Align Quality to Criticality

Elite Quality Grade

The Elite Quality Grade

Raw materials of higher criticality increase quality expectations.

We have developed the Elite quality grade to offer nearly all GMP quality attributes, without the associated cost burden. IVD market feedback indicates that the Elite grade is a good fit for critical raw material usage, balancing the need for consistency, transparency and control, against price.

Our Enhanced Quality Guidelines below outline the different levels of quality, documentation and supply chain traceability that we can provide to diagnostic manufacturers.

Enhanced Quality Guidelines

Consistency and Transparency with Change Control Management and Notification

We are committed to maintaining consistent manufacturing processes for Diagnostic Elite and GMP products.

We understand that changes in critical raw materials may require an IVD manufacturer to perform extensive impact analysis and validation. To reduce this risk and communicate changes in a timeframe that would limit the impact to commercialization, we have implemented:

  • Change controls
  • Enhanced change notifications

When changes are unavoidable, we are committed to providing you with earlier advanced notification.

The times indicated below are the minimum length of advance notification you would receive.

Timeline of Notification Prior to Change

Collaborate with Purpose: The Early Access Program (EAP)

Through the Diagnostic Elite portfolio and EAP, our goal is to develop enhanced, reliable products that meet your critical raw material requirements.

As the Diagnostic Elite program expands, we continue to work diligently to align new and optimized products with your evolving needs.

One key approach is our EAP, through which we provide the opportunity for IVD manufacturers to collaborate with us in selecting and designing specifications of new Diagnostic Elite products.

The program provides collaborating diagnostic manufacturers with:

  • Exclusive early access to new Diagnostic Elite products
  • The opportunity to influence product development through testing and feedback
  • Alignment of product with intended manufacturing use, minimizing time and cost associated with qualifying raw materials

Learn more about the Early Access Program

Early Access Program

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Product Description Quality Level Product No.
Apyrase (Grade VII) from potatoes Elite SRE0019
Butyrylcholinersterase from equine serum Elite SRE0020
Catalase from bovine liver Elite SRE0041
Galactose-1-phosphate Uridyltransferase from galactose-adapted yeast Elite SRE0008
Lipase from porcine pancreas Elite SRE0049
Lysostaphin from Staphylococcus staphylolyticus Elite SRE0018
Lyticase from Arthrobacter luteus Elite SRE0053
Neuraminidase from Clostridium perfringens Elite N2876
Pepsin from porcine gastric mucosa Elite SRE0001
Phosphatase, Acid from potatoes Elite SRE0048
Proteinase K from Tritirachium album, glycerol solution GMP SRE0005
Proteinase K from Tritirachium album, lyophilized Elite SRE0047
Thrombin from bovine plasma Elite SRE0003
Thymidine Phosphorylase, recombinant from Escherichia coli Elite SRE0006
γ-Globulins from bovine blood Elite SRE0011
3,3'-Diaminobenzidine tetrahydrochloride hydrate (DAB) Elite SRE0079
4-Nitrophenyl phosphate disodium salt hexahydrate Elite SRE0026
5-Methyltetrahydrofolic acid disodium salt (MTHFA) Elite SRE0010
Casein, Hammarsten from bovine milk Elite SRE0040
CaseiNSBlock alkaline treated casein from bovine milk Elite SRE0081
Heparin sodium salt from porcine intestinal mucosa Elite SRE0027
Protease Inhibitor Cocktail (PIC), powder GMP SRE0055
Trypsin inhibitor from Glycine max (soybean) Elite SRE0044
Monoclonal Anti-Cytokeratin, pan antibody (ascites fluid) GMP SRE0061
Monoclonal Anti-Human IgM (μ-chain specific) — Alkaline Phosphatase GMP SRE0058
Cardiolipin solution from bovine heart Elite SRE0029
Tris Buffered Saline (TBS) with Fish Gelatin (for ELISA) GMP SRE0071
Sodium deoxycholate Elite SRE0046
Ammonium acetate solution (for DNA/RNA precipitation) GMP SRE0035
BIS-TRIS, powder Elite B4429
BIS-TRIS propane, powder Elite B4679
Carbonate-Bicarbonate coating buffer (single use for ELISA) GMP-IVD* SRE0034
Emerald antibody diluent GMP-IVD* 936B
Guanidine hydrochloride solution, 6M GMP SRE0066
HEPES, 1M solution, sterile GMP SRE0065
HEPES, powder Elite H4034
HEPES sodium salt, powder Elite H3784
Lysis solution for blood DNA extraction GMP SRE0086
MES Hydrate, powder Elite M2933
MES sodium salt, powder Elite M3058
MOPS sodium salt, powder Elite M9024
Neutralization solution for blood DNA extraction GMP SRE0087
Phosphate Buffered Saline (PBS), with 10% BSA (for ELISA) GMP-IVD* SRE0036
Phosphate Buffered Saline (PBS), with TWEEN® wash buffer (for IHC) GMP-IVD* 934B
Phosphate buffer solution, 1M (for immunohistochemical procedures) GMP-IVD* SRE0064
PIPES, powder Elite P1851
Saline-Sodium Citrate (SSC) buffer, 20X concentrate (for ELISA) GMP SRE0068
SeqClin™ Wash Buffer, for Illumina high-throughput sequencing machines GMP SRE0076
SigMatrix Serum Diluent (with recombinant HSA, for ELISA and LC-MS) GMP-IVD* D4197
Tricine, powder Elite T5816
Tris-Acetate-EDTA buffer, 50X concentrate (for electrophoresis) GMP SRE0033
Tris-Borate-EDTA buffer, 10X concentrate (for electrophoresis) GMP SRE0062
Tris Buffered Saline (TBS), with TWEEN® wash buffer (for IHC) GMP-IVD* 935B
TRIS-EDTA buffer solution, pH 9.0 (for immunohistochemical procedures) GMP-IVD* SRE0063
Wash Buffer Tris with TWEEN® 20 (for ELISA) GMP-IVD* SRE0031
Wash Buffer Tris without TWEEN® 20 (for ELISA) GMP-IVD* SRE0032

*These products are registered as CE-IVD.