FDA.reportPublic FDA data

CD20 [BC44]

Primary DI
00847627043139
Brand
CD20 [BC44]
Company
BIOCARE MEDICAL LLC
Model
ACI3316C
Published
2026-09-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
NJTImmunohistochemistry Reagents And Kits

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NJTImmunohistochemistry Reagents And KitsHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847627043139PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847627043139008476270431398476270431390847627043139

GMDN Terms#

Term, Definition table
TermDefinition
CD20 cell marker IVD, antibodyOne or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of CD20 cell marker in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Regulatory Flags#

DUNS number
806617825
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00847627043153CD20 [BC44]ALI3316G72026-09-22
00847627043160CD20 [BC44]AVI3316G2026-09-22
00847627051622CK HMW + p63 + AMACR (RM)ALI3154DSG25 2026-05-14
00847627051639CK HMW + p63 + AMACR (RM)ALI3154DSL2026-05-14
00847627046147Treponema pallidum (Spirochete)APA135H2026-04-14
00847627040664SALL4NPAI384T402026-04-01
00847627041036Cyclin D1NPAI432T40 2026-04-01
00847627042095Carcinoembryonic Antigen (CEA{M})NPAI058T402026-04-01
00847627042194Caspase-3 (Cleaved)NPAI229T402026-04-01
00847627042590S100PNPAI3010T402026-04-01
00847627042859CD33NPAI3116T40 2026-04-01
00847627043726NeoPath Background Punisher NPRI10029T402026-03-11
00847627042637Pan TRK [RM423]NPAI3267T402026-02-19
00847627042279CK7NPAI339T402026-01-29
00847627043023NeoPATH Pro Rabbit Amp AP Plus KitNPRI10097KT135 2026-01-29
00847627043047NeoPATH Pro Universal AP Plus Polymer KitNPRI10101KT1352026-01-29
00847627043061NeoPATH Pro Antigen Retrieval 1 (AR1)NPRI10106T50 2026-01-29
00847627042033DesminNPAI036T402026-01-13
00847627042835CD19NPAI310T402026-01-13
00847627041937Myeloperoxidase (P)NPAI023T402026-01-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05055331340900BONDLEICA BIOSYSTEMS NEWCASTLE LTDNJT2026-09-25
05055331340917BONDLEICA BIOSYSTEMS NEWCASTLE LTDNJT2026-09-25
00810119671912Anti-HIF-1 alphaBIOGENEX LABORATORIESNJT2026-09-22
00810119672926Anti-Heat Shock Protein 27 (HSP 27)BIOGENEX LABORATORIESNJT2026-09-22
00810119673206Anti-Collagen IIIBIOGENEX LABORATORIESNJT2026-09-22
00810119674463Anti-Beta-Tubulin IIBIOGENEX LABORATORIESNJT2026-09-22
00810119674531Anti-Beta-Tubulin IVBIOGENEX LABORATORIESNJT2026-09-22
00810119675996Anti-Beta-Tubulin IVBIOGENEX LABORATORIESNJT2026-09-22
00810119676016Anti-Beta-Tubulin IIIBIOGENEX LABORATORIESNJT2026-09-22
00810119679000Anti-Collagen IIIBIOGENEX LABORATORIESNJT2026-09-22
00810119679277Anti-Beta-Tubulin IVBIOGENEX LABORATORIESNJT2026-09-22
00840542202629Anti-Alpha-TubulinBIOGENEX LABORATORIESNJT2026-09-22
00840542202636Anti-Alpha-TubulinBIOGENEX LABORATORIESNJT2026-09-22
00840542202650Anti-Alpha-TubulinBIOGENEX LABORATORIESNJT2026-09-22
00840542202667Anti-Alpha-TubulinBIOGENEX LABORATORIESNJT2026-09-22
00840542203138Anti-CDw75 (B cell)BIOGENEX LABORATORIESNJT2026-09-22
00840542203145Anti-CDw75 (B cell)BIOGENEX LABORATORIESNJT2026-09-22
00840542203152Anti-CDw75 (B cell)BIOGENEX LABORATORIESNJT2026-09-22
00840542203169Anti-CD74 (B cell)BIOGENEX LABORATORIESNJT2026-09-22
00840542203176Anti-CD74 (B cell)BIOGENEX LABORATORIESNJT2026-09-22
00840542203183Anti-CD74 (B cell)BIOGENEX LABORATORIESNJT2026-09-22
00840542203190Anti-CD74 (B cell)BIOGENEX LABORATORIESNJT2026-09-22
00840542203206Anti-CD74 (B cell)BIOGENEX LABORATORIESNJT2026-09-22
00840542203213Anti-CD74 (B cell)BIOGENEX LABORATORIESNJT2026-09-22
00840542203268Anti-CD45RC (T Cell)BIOGENEX LABORATORIESNJT2026-09-22
00840542203275Anti-CD45RC (T Cell)BIOGENEX LABORATORIESNJT2026-09-22
00840542203282Anti-CD45RC (T Cell)BIOGENEX LABORATORIESNJT2026-09-22
00840542203299Anti-CD45RC (T Cell)BIOGENEX LABORATORIESNJT2026-09-22
00840542203305Anti-CD45RC (T Cell)BIOGENEX LABORATORIESNJT2026-09-22
00840542203312Anti-CD45RC (T Cell)BIOGENEX LABORATORIESNJT2026-09-22