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Chang Medium® C with Gentamicin For Human Amniotic Fluid Cells

FDA UDI

Class I (US FDA UDI)

by Fujifilm Irvine Scientific, Inc.

Identity

Trade Name
Chang Medium® C with Gentamicin For Human Amniotic Fluid Cells FDA UDI
Generic Name
Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent FDA UDI
Device Name
Chang Medium C with Gentamicin 99418-90mL is longer being sold on its own. It can now only be purchased as part of the 99419-100ml kit. FDA UDI
Model / Reference
99418-90mL FDA UDI
Description
Chang Medium C with Gentamicin 99418-90mL is longer being sold on its own. It can now only be purchased as part of the 99419-100ml kit. FDA UDI

Identifiers

Catalog Number
99418 FDA UDI
Primary DI / UDI-DI
00857515006047 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 — 90 Milliliter FDA UDI

Chang Medium® C with Gentamicin For Human Amniotic Fluid Cells by Fujifilm Irvine Scientific, Inc. — Class I — FDA UDI — listed in FDA GUDID

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Fujifilm Irvine Scientific, Inc.

Sources (1)

  • FDA UDI 12c32686-c849-4a71-b734-b3da941c6f4a 38 fields · synced May 30, 2026