MP BIOMEDICALS, LLC

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

NINHYDRIN AND L-LEUCYL-L-ALANINE (FLUORIMETRIC), PHENYLALANINE (JNB) (4) RADIOIMMUNOASSAY, ACTH (CKG) (2) RADIOIMMUNOASSAY, CORTISOL (CGR) (2) RADIOIMMUNOASSAY, ALDOSTERONE (CJM) (1) RADIOIMMUNOASSAY, CHOLYGLYCINE, BILE ACIDS (KWW) (1)

Premarket Exempt

Clear

Aldosterone Double Antibody 125I RIA Kit - 00817830022269 Catalog Number : 07108202

Device Description : Radioimmunoassay for the quantitative determination of Aldosterone in human plas Radioimmunoassay for the quantitative determination of Aldosterone in human plasma or serum.

Device Class : 2

Duns Number: 137825928

Premarket Exempt : No

Product Code : CJM

Prescription Use : Yes

Device Count : 1

ImmuChem hACTH Double Antibody 125I RIA Kit - 00817830022276 Catalog Number : 07106101

Device Description : Radioimmunoassay for the quantitative determination of Adrencorticotropic Hormon Radioimmunoassay for the quantitative determination of Adrencorticotropic Hormone (hACTH) in human plasma.

Device Class : 2

Duns Number: 137825928

Premarket Exempt : No

Product Code : CKG

Prescription Use : Yes

Device Count : 1

ImmuChem hACTH Double Antibody 125I RIA Kit - 00817830022283 Catalog Number : 07106102

Device Class : 2

Duns Number: 137825928

Premarket Exempt : No

Product Code : CKG

Prescription Use : Yes

Device Count : 1

Conjugated Bile Acids 125I RIA Kit - 00817830022290 Catalog Number : 06B242918

Device Description : Radioimmunoassay for the quantitative determination of conjugated bile acids in Radioimmunoassay for the quantitative determination of conjugated bile acids in human serum or plasma.

Device Class : 2

Duns Number: 137825928

Premarket Exempt : No

Product Code : KWW

Prescription Use : Yes

Device Count : 1

ImmuChem Cortisol Coated Tube 125I RIA Kit - 00817830022306 Catalog Number : 07221102

Device Description : Radioimmunoassay for the quantitative determination of Cortisol in human serum or plasma.

Device Class : 2

Duns Number: 137825928

Premarket Exempt : No

Product Code : CGR

Prescription Use : Yes

Device Count : 1

Corti-Cote 125I RIA Kit - 00817830022313 Catalog Number : 06B256440

Device Description : Radioimmunoassay for the quantitative determination of Cortisol in human serum or plasma.

Device Class : 2

Duns Number: 137825928

Premarket Exempt : No

Product Code : CGR

Prescription Use : Yes

Device Count : 1

Neonatal Phenylalanine ELISA Kit (without membrane) - 00817830022320 Catalog Number : 07575300

Device Description : ELISA kit for the quantitative detection of phenylalanine in neonatal blood spots.

Device Class : 2

Duns Number: 137825928

Premarket Exempt : No

Product Code : JNB

Prescription Use : Yes

Device Count : 1

Neonatal Phenylalanine ELISA Kit (with membrane) - 00817830022337 Catalog Number : 07575303

Device Description : ELISA kit for the quantitative detection of phenylalanine in neonatal blood spots.

Device Class : 2

Duns Number: 137825928

Premarket Exempt : No

Product Code : JNB

Prescription Use : Yes

Device Count : 1

Neonatal Phenylalanine ELISA Kit (without membrane) - 00817830022344 Catalog Number : 07575305

Device Description : ELISA kit for the quantitative detection of phenylalanine in neonatal blood spots.

Device Class : 2

Duns Number: 137825928

Premarket Exempt : No

Product Code : JNB

Prescription Use : Yes

Device Count : 1

Neonatal Phenylalanine ELISA Kit (with membrane) - 00817830022351 Catalog Number : 07575306

Device Description : ELISA kit for the quantitative detection of phenylalanine in neonatal blood spots.

Device Class : 2

Duns Number: 137825928

Premarket Exempt : No

Product Code : JNB

Prescription Use : Yes

Device Count : 1

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