MP BIOMEDICALS, LLC

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Filters

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

ACID, FOLIC, RADIOIMMUNOASSAY (CGN) (2) RADIOIMMUNOASSAY, CORTISOL (CGR) (2) RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE (JLW) (2)

Premarket Exempt

Clear

CT Neonatal hTSH 1000 Kit - 00817830022573 Catalog Number : 07-294306

Device Description : For the quantitative determination of TSH in Neonatal Blood.

Device Class : 2

Duns Number: 137825928

Premarket Exempt : No

Product Code : JLW

Prescription Use : Yes

Device Count : 1

CT hTSH 1000 Tube Kit - 00817830022580 Catalog Number : 07-294106

Device Description : For the quantitative determination of TSH in Serum or Plasma.

Device Class : 2

Duns Number: 137825928

Premarket Exempt : No

Product Code : JLW

Prescription Use : Yes

Device Count : 1

SimulTRAC-SNB Vitamin B12/Folate 125I RIA Kit - 00817830022597 Catalog Number : 06B264806

Device Description : Radioimmunoassay for the quantitative determination of Vitamin B12 and Folate in Radioimmunoassay for the quantitative determination of Vitamin B12 and Folate in human plasma or serum.

Device Class : 2

Duns Number: 137825928

Premarket Exempt : No

Product Code : CGN

Prescription Use : Yes

Device Count : 1

SimulTRAC-S Vitamin B12/Folate 125I RIA Kit - 00817830022603 Catalog Number : 06B254819

Device Description : For the cuantitative determination of Vitamin B12 and Folate in Serum or Plasma.

Device Class : 2

Duns Number: 137825928

Premarket Exempt : No

Product Code : CGN

Prescription Use : Yes

Device Count : 1

Cortisol CT 500 Tube Kit - 00817830022610 Catalog Number : 07-221105

Device Description : For the quantitative determination of Cortisol in Serum or Plasma.

Device Class : 2

Duns Number: 137825928

Premarket Exempt : No

Product Code : CGR

Prescription Use : Yes

Device Count : 1

Cortisol CT 1000 Tube Kit - 00817830022627 Catalog Number : 07-221106

Device Description : For the quantitative determination of Cortisol in Serum or Plasma.

Device Class : 2

Duns Number: 137825928

Premarket Exempt : No

Product Code : CGR

Prescription Use : Yes

Device Count : 1

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