FDA.reportPublic FDA data

Opti-MEM® I Reduced Serum Medium

Primary DI
30190302004767
Brand
Opti-MEM® I Reduced Serum Medium
Company
LIFE TECHNOLOGIES CORPORATION
Model
51985034
Published
2016-08-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
false

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
30190302004767PackageGS110Not in Commercial Distribution
10190302004763PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3019030200476730190302004767
1019030200476310190302004763

GMDN Terms#

Term, Definition table
TermDefinition
Cell culture medium IVDA liquid based tissue culture medium containing essential nutrients, sugars, amino acids and growth factors, intended to be used for the in-vitro maintenance, sustenance, and cultivation of human cells from a clinical specimen for diagnostic purposes.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118793157
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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

Other Devices From This Company#

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10190302018999TaqPath™ COVID-19, Flu A, Flu B, RSV Select Positive Control9636122025-02-17
10190302019002TaqPath™ COVID-19, Flu A, Flu B, RSV Select Negative Control9636092025-02-17
10190302019019TaqPath™ 1-Step Select Master Mix (No ROX)A56518A561232025-02-17
10190302019026TaqPath™ COVID-19, Flu A, Flu B, RSV Select AssayA564412025-02-17
10190302019033TaqPath™ COVID-19, Flu A, Flu B, RSV Select Positive Control9636132025-02-17
10190302019040TaqPath™ COVID-19, Flu A, Flu B, RSV Select Negative Control9636082025-02-17
10190302019057TaqPath™ 1-Step Select Master Mix (No ROX)A565192025-02-17
10190302019422Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Assay KitA572972025-02-17
80190302019438Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Control Dilution BufferA577402025-02-17
10190302019446Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Control9661362025-02-17
10190302006385Oncomine™ Dx Target TestA324412017-06-27
10190302005197Aim -V™ MediumA18398DJ2016-08-01
10190302012041Human CD99 FITC ConjugateMHCD99012018-06-15
10190302012058Human CD99 R-PE ConjugateMHCD99042018-06-15
10190302012065Human CXCR4 (CD184) R-PE ConjugateMHCXCR4042018-06-15
10190302012164Anti-Human HLA-DR (Class II) FITC ConjugateMHLDR012018-06-15
10190302012171Anti-Human HLA-DR (Class II) R-PE ConjugateMHLDR042018-06-15
10190302012188Anti-Human HLA-DR (Class II) APC ConjugateMHLDR052018-06-15
10190302012195Anti-Human HLA-DR (Class II) PE-Texas Red® ConjugateMHLDR172018-06-15

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