Identity
- Trade Name
- PL Chip Reservoir Set FDA UDI
- Generic Name
- Assay container IVD, single-use FDA UDI
- Device Name
- Disposable accessories for use with the PL Chip FDA UDI
- Model / Reference
- N/A FDA UDI
- Description
- Disposable accessories for use with the PL Chip FDA UDI
Identifiers
- Catalog Number
- 18003 FDA UDI
- Primary DI / UDI-DI
- 04589448510099 FDA UDI
- 510(k) Number
- K191364 FDA UDI
- FDA Product Code
- JOZ FDA UDI
- GMDN Term
- Assay container IVD, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.5700 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
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Assay container IVD, single-use
PL Chip Reservoir Set by Zacros Corporation — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Assay container IVD, single-use.
- Tube 4ml, 92x15.3mm, PP — Sarstedt Aktiengesellschaft & Co.KG · Class I
- Micro tube 2ml, PP — Sarstedt Aktiengesellschaft & Co.KG · Class I
- Multiply®-µStrip 0.2ml chain — Sarstedt Aktiengesellschaft & Co.KG · Class I
- Tube 5ml, 75x12mm, PS — Sarstedt Aktiengesellschaft & Co.KG · Class I
- ASSY, Reag.Disp.Card, PrepKit 97, BenchMark — Ventana Medical Systems · Class I
- Tube 10 ml 92 x 15 ml — Sarstedt Aktiengesellschaft & Co.KG · Class I
- FB Tube 2.5ml, 75x13 (round) — Sarstedt Aktiengesellschaft & Co.KG · Class I
- ASSY RGT DISPENSER CARD BMK PREP KIT 222 — Ventana Medical Systems · Class I
Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Unknown |
| 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
- Zacros Corporation
Sources (2)
- FDA UDI 5cd9a68a-3cfc-4999-ade4-0bdd1befa57b 35 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 18, 2026