FDA.reportPublic FDA data

Chiwell Biotechnology

Primary DI
06979203760278
Brand
Chiwell Biotechnology
Company
Ningbo Chiwell Biotechnology Co., Ltd
Model
5L
Published
2026-01-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KIPFormulations, Balanced Salt Solutions

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KIPFormulations, Balanced Salt SolutionsHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16979203760275PackageGS14In Commercial Distribution
06979203760278PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697920376027516979203760275
06979203760278069792037602786979203760278

GMDN Terms#

Term, Definition table
TermDefinition
Frozen tissue fixative IVDA solution intended to be used as a fixative in the processing of frozen tissue sections derived from biological tissues or clinical specimens, for subsequent in vitro diagnostic analysis.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
413940020
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06979203760285Chiwell Biotechnology24×50mm2026-01-07
06979203760025Chiwell BiotechnologyE62025-12-29
06979203760032Chiwell BiotechnologyCW-1000+CW-8002025-12-29
06979203760049Chiwell BiotechnologyCW-10002025-12-29
06979203760056Chiwell BiotechnologyCW-8002025-12-29
06979203760018Chiwell BiotechnologyE82025-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05407010128505DPBS 0.0095M(PO4) w/o Ca,Mg-500mL sampleLonza VerviersKIP2025-08-20
05407010127454PBS w/o Ca-Mg 5L JerrycanLonza VerviersKIP2025-06-11
05407010127461PBS w/o Ca-Mg 1L bottleLonza VerviersKIP2025-06-11
05407010127478PBS w/o Ca-Mg Tween 20 0.1% 5L jerrycanLonza VerviersKIP2025-06-11
05407010127485Physiologic Water Tween20 0.05% 5LjerrycLonza VerviersKIP2025-06-11
05407010127492DPBS 1X with 1M NaCl - 10 L BagLonza VerviersKIP2025-06-11
05407010127508DPBS 1X - 20 L Bag Lonza VerviersKIP2025-06-11
05407010127515DPBS 1X with 0.06M NaCl - 20L bagLonza VerviersKIP2025-06-11
05407010127522DPBS 1X with 0.4M NaCl - 20L bagLonza VerviersKIP2025-06-11
05407010127539DPBS 1X with 0.08M NaCl - 10 L bagLonza VerviersKIP2025-06-11
05407010127546IBEX PBS : 1000L BagLonza VerviersKIP2025-06-11
05407010127553IBEX PBS : 1L Bag SAMPLELonza VerviersKIP2025-06-11
05407010127560DPBS IC51 1L bagLonza VerviersKIP2025-06-11
05407010127577DPBS IC51 20LLonza VerviersKIP2025-06-11
05407010127133DPBS 0.0095M(PO4) w/o Ca,Mg,500mlINTERNELonza VerviersKIP2025-05-26
05407010127140DPBS 0.0095M(PO4) w/o Ca, Mg, 1L INTERNELonza VerviersKIP2025-05-26
05407010126938DPBS 0.0095M(PO4) w/o Ca,Mg-250ml sample Lonza VerviersKIP2025-05-14
05407010126174NCTF Powder - 5LLonza VerviersKIP2025-03-20
05407010125726NCTF Powder - 380gLonza VerviersKIP2025-01-08
16974488990713iCleanHuachenyang (Shenzhen) Technology Co., LtdKIP2023-10-24
16974488990720iCleanHuachenyang (Shenzhen) Technology Co., LtdKIP2023-10-24
06974488990716iCleanHuachenyang (Shenzhen) Technology Co., LtdKIP2023-10-24
06974488990723iCleanHuachenyang (Shenzhen) Technology Co., LtdKIP2023-10-24
10190302001069Phosphate-Buffered Saline (PBS) (1X), pH 7.4LIFE TECHNOLOGIES LIMITEDKIP2023-10-02
10190302002660Hanks’ Balanced Salt Solution (HBSS) (1X)LIFE TECHNOLOGIES LIMITEDKIP2023-10-02
10190302002707Dulbecco’s Phosphate Buffered Saline (D-PBS) (1X)LIFE TECHNOLOGIES LIMITEDKIP2023-10-02
10190302002714Dulbecco’s Phosphate Buffered Saline (D-PBS) (1X)LIFE TECHNOLOGIES LIMITEDKIP2023-10-02
10190302002752Hanks’ Balanced Salt Solution (HBSS) (10X)LIFE TECHNOLOGIES LIMITEDKIP2023-10-02
10190302002776Dulbecco’s Phosphate Buffered Saline (D-PBS) (10X)LIFE TECHNOLOGIES LIMITEDKIP2023-10-02
10190302002813Hanks’ Balanced Salt Solution (HBSS) (1X)LIFE TECHNOLOGIES LIMITEDKIP2023-10-02