MONOBIND, INC.

Address:100 N. POINTE DR.,LAKE FOREST,CA,92630,US

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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

RADIOIMMUNOASSAY, DEHYDROEPIANDROSTERONE (FREE AND SULFATE) (JKC) (3) RADIOIMMUNOASSAY, ESTRADIOL (CHP) (2) RADIOIMMUNOASSAY, ESTRIOL (CGI) (2) RADIOIMMUNOASSAY, PROGESTERONE (JLS) (2) RADIOIMMUNOASSAY, 17-HYDROXYPROGESTERONE (JLX) (1)

Premarket Exempt

No Yes

Clear

Monobind AccuLite DHEA-S CLIA Kit - 192 Wells - 00816870022789 Catalog Number : 5175-300B

Device Class : 1

Duns Number: 083155515

Premarket Exempt : Yes

Product Code : JKC

Prescription Use : No

Device Count : 1

Monobind AccuLite DHEA CLIA Kit - 96 Wells - 00816870022796 Catalog Number : 7475-300A

Device Class : 1

Duns Number: 083155515

Premarket Exempt : Yes

Product Code : JKC

Prescription Use : No

Device Count : 1

Monobind AccuLite DHEA CLIA Kit - 192 Wells - 00816870022802 Catalog Number : 7475-300B

Device Class : 1

Duns Number: 083155515

Premarket Exempt : Yes

Product Code : JKC

Prescription Use : No

Device Count : 1

Monobind AccuLite E2 CLIA Kit - 96 Wells - 00816870022819 Catalog Number : 4975-300A

Device Class : 1

Duns Number: 083155515

Premarket Exempt : Yes

Product Code : CHP

Prescription Use : No

Device Count : 1

Monobind AccuLite E2 CLIA Kit - 192 Wells - 00816870022826 Catalog Number : 4975-300B

Device Class : 1

Duns Number: 083155515

Premarket Exempt : Yes

Product Code : CHP

Prescription Use : No

Device Count : 1

Monobind AccuLite uE3 CLIA Kit - 96 Wells - 00816870022833 Catalog Number : 5075-300A

Device Class : 1

Duns Number: 083155515

Premarket Exempt : Yes

Product Code : CGI

Prescription Use : No

Device Count : 1

Monobind AccuLite uE3 CLIA Kit - 192 Wells - 00816870022840 Catalog Number : 5075-300B

Device Class : 1

Duns Number: 083155515

Premarket Exempt : Yes

Product Code : CGI

Prescription Use : No

Device Count : 1

Monobind AccuLite Progesterone CLIA Kit - 96 Wells - 00816870022857 Catalog Number : 4875-300A

Device Class : 1

Duns Number: 083155515

Premarket Exempt : Yes

Product Code : JLS

Prescription Use : No

Device Count : 1

Monobind AccuLite Progesterone CLIA Kit - 192 Wells - 00816870022864 Catalog Number : 4875-300B

Device Class : 1

Duns Number: 083155515

Premarket Exempt : Yes

Product Code : JLS

Prescription Use : No

Device Count : 1

Monobind AccuLite 17OHP CLIA Kit - 96 Wells - 00816870022871 Catalog Number : 5275-300A

Device Class : 1

Duns Number: 083155515

Premarket Exempt : Yes

Product Code : JLX

Prescription Use : No

Device Count : 1

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