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Chang Amnio

FDA UDI

Class I (US FDA UDI)

by Fujifilm Irvine Scientific, Inc.

Identity

Trade Name
Chang Amnio FDA UDI
Generic Name
Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent FDA UDI
Model / Reference
99473-500ML FDA UDI

Identifiers

Catalog Number
99473 FDA UDI
Primary DI / UDI-DI
00893727002699 FDA UDI
FDA Product Code
KIT FDA UDI
KIQ 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
864.2260 FDA UDI
Commercial Distribution
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 — 500 Milliliter FDA UDI

Category: Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent

Chang Amnio by Fujifilm Irvine Scientific, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent.

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 92108ccf-951d-4367-a60b-24363ed1ee61 36 fields · synced Jun 1, 2026