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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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CD39 [EPR20627] - 00847627030566

No Description
BIOCARE MEDICAL LLC
OPAI3283T60
In Commercial Distribution

  • 00847627030566 ()


  • Multiple CD cell marker IVD, antibody

CD39 [EPR20627] - 00847627030559

No Description
BIOCARE MEDICAL LLC
API3283AA
In Commercial Distribution

  • 00847627030559 ()


  • Multiple CD cell marker IVD, antibody

CD39 [EPR20627 - 00847627030542

Alternate name : CD39 [EPR20627]
BIOCARE MEDICAL LLC
ACI3283C
In Commercial Distribution

  • 00847627030542 ()


  • Multiple CD cell marker IVD, antibody

CD39 [EPR20627] - 00847627030535

No Description
BIOCARE MEDICAL LLC
ACI3283A
In Commercial Distribution

  • 00847627030535 ()


  • Multiple CD cell marker IVD, antibody

CD4 + CD8 - 00847627004437

No Description
BIOCARE MEDICAL LLC
API3157DSAA
In Commercial Distribution

  • 00847627004437 ()


  • Multiple CD cell marker IVD, antibody

L26 + CD3 - 00847627011435

No Description
BIOCARE MEDICAL LLC
PM237DSAA
In Commercial Distribution

  • 00847627011435 ()


  • Multiple CD cell marker IVD, antibody

CD-Chex Plus BC - 00844509000549

A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 5 vials each of CD4L and Normal level.
STRECK, INC.
213376
In Commercial Distribution

  • 00844509000549 ()

  • Total Volume: 3.0 Milliliter
213376

  • Multiple CD cell marker IVD, control

CD-Chex Plus BC - 00844509000532

A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 2 vials each of CD4L and Normal level.
STRECK, INC.
213375
Not in Commercial Distribution

  • 00844509000532 ()

  • Total Volume: 3.0 Milliliter
213375

  • Multiple CD cell marker IVD, control

CD-Chex CD34 - 00844509000501

A positive procedural control for enumerating CD34 positive cells by flow cytometry. Contains 2 vials each of level 1 and 2.
STRECK, INC.
213339
In Commercial Distribution

  • 00844509000501 ()

  • Total Volume: 1.0 Milliliter
213339

  • Multiple CD cell marker IVD, control

CD-Chex CD34 - 00844509000495

A positive procedural control for enumerating CD34 positive cells by flow cytometry. Contains 1 vial each of level 1 and 2.
STRECK, INC.
213338
In Commercial Distribution

  • 00844509000495 ()

  • Total Volume: 1.0 Milliliter
213338

  • Multiple CD cell marker IVD, control
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