FDA.report

Chang Medium C

Primary DI
00893727002460
Company
FUJIFILM IRVINE SCIENTIFIC, INC.
Model
T101-059
Catalog number
T101
Device description
CHANG C L-500ml
Published
2021-04-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
false

Related Records

Regulatory Flags

DUNS number
057475246
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Identifiers

IdentifierTypeAgencyPackage quantityStatus
00893727002460PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
00893727002460PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
KITMedia And Components, Synthetic Cell And Tissue Culture1Hematology864.2220NEligible

Premarket Submissions

No records found.

Premarket Details

No records found.

GMDN Terms

TermDefinition
Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagentA substance or reactant intended to be used for the suspension, preservation and storage of amnioic fluid and/or chorionic villus sample (CVS) fluid of a clinical specimen, in order to maintain suitability for karyotyping or chromosome evaluation.

Device Sizes

TypeValueText
Total Volume500 Milliliter

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
8004375706tmrequest@irvinesci.com

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