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Freezing Medium - TEST Yolk Buffer (TYB) with Glycerol and Gentamicin
FDA UDIFDA 510(k)EUDAMEDClass II (US FDA UDI)
510(k) K991421
Identity
- Trade Name
- Freezing Medium - TEST Yolk Buffer (TYB) with Glycerol and Gentamicin FDA UDI
- Generic Name
- IVF medium FDA UDI
- Device Name
- Freezing Medium With Gentamicin FDA UDI
- Model / Reference
- 90128-20X5mL FDA UDI
- Description
- Freezing Medium With Gentamicin FDA UDI
Identifiers
- Catalog Number
- 90128 FDA UDI
- Primary DI / UDI-DI
- 00893727002217 FDA UDI
- FDA Product Code
- MQL FDA UDI
- GMDN Term
- IVF medium FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.6180 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
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 — 5 Milliliter FDA UDI
Category: IVF medium
Freezing Medium - TEST Yolk Buffer (TYB) with Glycerol and Gentamicin by Fujifilm Irvine Scientific, Inc. — Class II — FDA_510K, MDD — listed in FDA GUDID…
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Unknown
MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K991421 | Class II | Active |
| EUDAMED | European Union | MDD | — | Class II | Unknown |
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Manufacturer
- Manufacturer
- Fujifilm Irvine Scientific, Inc.
- FDA Applicant
- Irvine Scientific Sales Co., Inc.
Sources (3)
- FDA UDI abab99f5-42bf-420e-8ce6-ae72b79f374e 61 fields · synced Jun 18, 2026
- FDA 510(k) K991421 1 fields · synced Jun 9, 2026
- EUDAMED 1 fields · synced Jun 3, 2026