FDA.report

Monobind AccuLite hCG Extended Range CLIA Kit - 96 Wells

Primary DI
00816870022604
Brand
Monobind AccuLite hCG Extended Range CLIA Kit - 96 Wells
Company
MONOBIND, INC.
Model
8875-300
Catalog number
8875-300A
Published
2019-02-11
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

Related Records

Contact Domains

Product Codes

CodeName
DHASYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN

Product Code Classifications

CodeDeviceSpecialtyClass
DHASystem, Test, Human Chorionic GonadotropinClinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00816870022604PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00816870022604008168700226048168700226040816870022604

GMDN Terms

TermDefinition
Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total human chorionic gonadotropin (HCG), which may include intact HCG, nicked HCG, free alpha-HCG subunits and/or free beta-HCG subunits, in a clinical specimen using a chemiluminescent immunoassay method.

Device Sizes

TypeValueUnit
Width7.75Inch

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Handling Environment Temperature
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(949)951-2665info@monobind.com

Regulatory Flags

DUNS number
083155515
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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