Identity
- Trade Name
- Chang Medium® C with Gentamicin FDA UDI
- Generic Name
- Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent FDA UDI
- Device Name
- Chang Medium C with Gentamicin FDA UDI
- Model / Reference
- 99418-450mL FDA UDI
- Description
- Chang Medium C with Gentamicin FDA UDI
Identifiers
- Catalog Number
- 99418 FDA UDI
- Primary DI / UDI-DI
- 00857515006054 FDA UDI
- FDA Product Code
- KIT FDA UDI
- GMDN Term
- Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.2220 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 450 Milliliter FDA UDI
Chang Medium® C with Gentamicin by Fujifilm Irvine Scientific, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Fujifilm Irvine Scientific, Inc.
Sources (1)
- FDA UDI 6fb3a5da-26f1-4c26-a402-340146d9d03c 38 fields · synced Jun 8, 2026