Identity
- Trade Name
- ImmunoCAP Tryptase Calibrators FDA UDI
- Generic Name
- Mast cell protease IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Contains one vial of each Tryptase Calibrator (Cal-1, Cal-5, Cal-12.5, Cal-50, Cal-200) to form a complete calibration curve for the ImmunoCAP Tryptase method. FDA UDI
- Model / Reference
- 10-9526-01 FDA UDI
- Description
- Contains one vial of each Tryptase Calibrator (Cal-1, Cal-5, Cal-12.5, Cal-50, Cal-200) to form a complete calibration curve for the ImmunoCAP Tryptase method. FDA UDI
Identifiers
- Catalog Number
- 10-9526-01 FDA UDI
- Primary DI / UDI-DI
- 07333066000909 FDA UDI
- 510(k) Number
- K173704 FDA UDI
- FDA Product Code
- OYL FDA UDI
- GMDN Term
- Mast cell protease IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5760 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Mast cell protease IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Tryptase Calibrators by Phadia GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Mast cell protease IVD, kit, enzyme immunoassay (EIA).
- ImmunoCAP Tryptase Calibrator Strip — Phadia GmbH · Class II
- ImmunoCAP Tryptase Curve Control 1 — Phadia GmbH · Class II
- ImmunoCAP Tryptase Calibrator Strip — Phadia GmbH · Class II
- ImmunoCAP Tryptase Conjugate 50 — Phadia GmbH · Class II
- ImmunoCAP Tryptase Curve Control 1 — Phadia GmbH · Class II
- ImmunoCAP Tryptase Curve Control Strip — Phadia GmbH · Class II
- ImmunoCAP Tryptase — Phadia GmbH · Class II
Cleared under the same submission
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Phadia GmbH
Sources (1)
- FDA UDI 70c8c08b-af46-4111-b041-8f52083fbb60 37 fields · synced May 30, 2026