Identity
- Trade Name
- ZYM A FDA UDI
- Generic Name
- Multiple Staphylococcus bacterial species culture isolate identification IVD, kit FDA UDI
- Device Name
- ZYM A is a reagent associated to API® Staph (20 500), API® 20 Strep (20 600), API® Coryne (20 900), API® ZYM (25 200) FDA UDI
- Model / Reference
- 70494 FDA UDI
- Description
- ZYM A is a reagent associated to API® Staph (20 500), API® 20 Strep (20 600), API® Coryne (20 900), API® ZYM (25 200) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03573026142001 FDA UDI
- FDA Product Code
- JTO FDA UDI
- GMDN Term
- Multiple Staphylococcus bacterial species culture isolate identification IVD, kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.2660 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
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
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: Multiple Staphylococcus bacterial species culture isolate identification IVD, kit
Zym A by Biomerieux , Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Multiple Staphylococcus bacterial species culture isolate identification IVD, kit.
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- Prolex Staph Xtra Latex Kit (100 tests) — PRO-LAB, INCORPORATED · Class I
- VP A + VP B — BIOMERIEUX , INC. · Class I
- ZYM B — BIOMERIEUX , INC. · Class I
- FB — BIOMERIEUX , 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
- Biomerieux , Inc.
Sources (1)
- FDA UDI cf496232-c727-458a-8e90-e64b6b3a63b6 34 fields · synced May 29, 2026