FDA.reportPublic FDA data

Chang C 14ML Frozen Supplement

Primary DI
00857515006115
Brand
Chang C 14ML Frozen Supplement
Company
FUJIFILM IRVINE SCIENTIFIC, INC.
Model
C106-14ML
Catalog number
C106
Device description
Chang C 14ML Frozen Supplement
Published
2021-04-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KITMedia And Components, Synthetic Cell And Tissue Culture

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KITMedia And Components, Synthetic Cell And Tissue CultureHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857515006115PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857515006115008575150061158575150061150857515006115

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Total Volume14Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius-10 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8004375706tmrequest@irvinesci.com

Regulatory Flags#

DUNS number
057475246
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00893727002200Freezing Medium - TEST Yolk Buffer (TYB) with Glycerol and Gentamicin90128-100mL901282016-09-10
00893727002361ISolate®99264-2x50mL992642016-09-10
00893727002903Human Serum Albumin Solution9988-100mL99882016-09-10
00893727002002Oil for Embryo Culture9305-100mL93052016-09-10
00893727002019PBS 1X - Dulbecco's Phosphate Buffered Saline Solution9235-500mL92352016-09-10
00893727002071Sperm Washing Medium9983-100mL99832016-09-10
00893727002088Sperm Washing Medium9983-12X12mL99832016-09-10
00893727002101Human Serum Albumin Solution9988-12X5mL99882016-09-10
00893727002125Hyaluronidase Solution90101-5X1mL901012016-09-10
008937270021637% PVP Solution with HSA90121-5X0.5mL901212016-09-10
0089372700217010% PVP Solution with HSA90123-5X0.5mL901232016-09-10
00893727002217Freezing Medium - TEST Yolk Buffer (TYB) with Glycerol and Gentamicin90128-20X5mL901282016-09-10
00893727002354ISolate®99264-12X6mL992642016-09-10
00893727002378ISolate® Concentrate99306-100ml993062016-09-10
00893727002781Oil for Embryo Culture9305-500mL93052016-09-10
00893727002859ISolate® Stock Solution99275-100ML992752016-09-10
00893727002194Modified HTF Medium-HEPES with Gentamicin90126-100mL901262016-09-10
00893727002804HTF Medium with Gentamicin90125-100mL901252016-09-10
00893727002910HTF Medium with Gentamicin90125-500mL901252016-09-10
00893727002927Modified HTF Medium-HEPES with Gentamicin90126-500mL901262016-09-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10190302001236Minimum Essential Medium (MEM) (1X)LIFE TECHNOLOGIES LIMITEDKIT2023-10-02
10190302003650Dulbeccos Modified Eagle MediumLIFE TECHNOLOGIES LIMITEDKIT2023-10-02
10190302004459BME, Basal Medium (Eagle) (1X)LIFE TECHNOLOGIES LIMITEDKIT2023-10-02
10190302004718Minimum Essential Medium (MEM) (1X)LIFE TECHNOLOGIES LIMITEDKIT2023-10-02
00840075400141X-VIVO 10 w/o Gent,PR&w/ RecTrnsfrn 50LLonza Walkersville, Inc.KIT2022-12-08
00840075400202STD ProCHO 5 Powder, 500 LLonza Walkersville, Inc.KIT2022-12-08
00840075400233RoosterBasal(TM)-MSC-CC, 500mlLonza Walkersville, Inc.KIT2022-12-08
00840075400264Insect-XPRESS w/ L-Gln 1 LLonza Walkersville, Inc.KIT2022-12-08
00840075400301TheraPEAK™ SfAAV™ 1L bottleLonza Walkersville, Inc.KIT2022-12-08
00840075400349VEGGIE 10 MEDIUM WITH ADDITIVES, 200LLonza Walkersville, Inc.KIT2022-12-08
00840075400356TheraPEAK™ X-VIVO™ 15 w/o Gent or PR, 1LLonza Walkersville, Inc.KIT2022-12-08
00840075400363Solution E LifeCell p/n 131P0063, lL botLonza Walkersville, Inc.KIT2022-12-08
00840075400370TheraPEAK™ Lymphocyte Separation MediumLonza Walkersville, Inc.KIT2022-12-08
00840075400493UltraCULTURE, 200L bagLonza Walkersville, Inc.KIT2022-12-08
00840075400653TheraPEAK™ X-VIVO™ 15 w/o Gent or PR, 5LLonza Walkersville, Inc.KIT2022-12-08
00840075400677HAL-MEM WITH LAH #00-0704-00, 200L bagLonza Walkersville, Inc.KIT2022-12-08
00840075400936Solution E LifeCell 131P0077-02, 100L drLonza Walkersville, Inc.KIT2022-12-08
00840075400981RPMI1640 4.5g/L GLUC,NAHCO3,W/O GLUT,50LLonza Walkersville, Inc.KIT2022-12-08
00840075400998TheraPEAK ACK Lysing Buffer (1x), 100mLLonza Walkersville, Inc.KIT2022-12-08
00840075401049RPMI 1640 W/GLUT. & GENTAM., 500 ml botLonza Walkersville, Inc.KIT2022-12-08
00840075401100Dulbecco's (PBS) w/o Ca and Mg, lL botLonza Walkersville, Inc.KIT2022-12-08
00840075401179SOLUTION Z LIFECELL P/N 131P0120, 75LLonza Walkersville, Inc.KIT2022-12-08
008400754012234Cell Insect CD Medium, 1LLonza Walkersville, Inc.KIT2022-12-08
00840075401292STD PowerCHO Advance 100 LLonza Walkersville, Inc.KIT2022-12-08
00840075401414ProCHO 5 serum-free media 1 LLonza Walkersville, Inc.KIT2022-12-08
00840075401476STD PowerCHO Advance 10LLonza Walkersville, Inc.KIT2022-12-08
00840075401483Solution Z LifeCell P/N 131P0115, 1LLonza Walkersville, Inc.KIT2022-12-08
00840075401544STD PowerCHO-2w/oPEG,InsProlpCit2777.8gLonza Walkersville, Inc.KIT2022-12-08
00840075401629ProCHO 4 w/o Phenol Red, 1 LLonza Walkersville, Inc.KIT2022-12-08