Identity
- Trade Name
- IDK® Pancreatic Elastase ELISA FDA UDI
- Generic Name
- Pancreatic elastase (PE) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Model / Reference
- K 6915.20.US FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04050598008540 FDA UDI
- FDA Product Code
- JNN FDA UDI
- GMDN Term
- Pancreatic elastase (PE) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1725 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Pancreatic elastase (PE) IVD, kit, enzyme immunoassay (EIA)
IDK® Pancreatic Elastase ELISA by Immundiagnostik, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pancreatic elastase (PE) IVD, kit, enzyme immunoassay (EIA).
- Pancreatic Elastase Chemiluminescence ELISA — American Laboratory Products Company · Class I
- ScheBo® Pancreatic Elastase 1™ — ScheBo r. Biotech Aktiengesellschaft · Class I
- LIAISON Elastase-1 — Diasorin Inc.
- ALPCO Pancreatic Elastase CLIA — American Laboratory Products Company · Class I
- Pancreatic Elastase ELISA — American Laboratory Products Company · Class I
- Pancreatic Elastase ELISA — Seramun Diagnostica GmbH
- Pancreatic Elastase ELISA — Seramun Diagnostica GmbH · Class I
- IDK® Pancreatic Elastase ELISA — IMMUNDIAGNOSTIK, INC. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Immundiagnostik, Inc.
Sources (1)
- FDA UDI b91c9d80-c4a4-47e3-a005-16ce53794bdf 33 fields · synced Jun 7, 2026