FDA.reportPublic FDA data

BioCheck hCG EIA Test Kit

Primary DI
00850392007275
Brand
BioCheck hCG EIA Test Kit
Company
BIOCHECK, INC.
Model
BC-1027
Catalog number
BC-1027
Device description
The BioCheck hCG EIA Test Kit is intended for the quantitative determination of human chorionic gonadotropin (hCG) concentration in human serum.
Published
2019-10-08
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JHIVisual, Pregnancy Hcg, Prescription Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JHIVisual, Pregnancy Hcg, Prescription UseClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K991741000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K991741000BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027Biocheck, Inc.1999-07-22JHI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850392007275PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850392007275008503920072758503920072750850392007275

GMDN Terms#

Term, Definition table
TermDefinition
Total human chorionic gonadotropin (HCG) IVD, kit, enzyme immunoassay (EIA)A 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 an enzyme immunoassay (EIA) method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(650)573-1968info@biocheckinc.com

Regulatory Flags#

DUNS number
171857493
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850392007015BioCheck TSH EIA Test KitBC-1001BC-10012019-10-08
00850392007039BioCheck U-TSH EIA Test KitBC-1003BC-10032019-10-08
00850392007053BioCheck T3 EIA Test KitBC-1005BC-10052019-10-08
00850392007077BioCheck T4 EIA Test KitBC-1007BC-10072019-10-08
00850392007176BioCheck Myoglobin EIA Test KitBC-1117BC-11172019-10-08
00850392007190BioCheck High Sensitive CRP EIA Test KitBC-1119BC-11192019-10-08
00850392007251BioCheck Human Ferritin EIA Test KitBC-1025BC-10252019-10-08
00850392007350BioCheck IgE EIA Test KitBC-1035BC-10352019-10-08
00850392007619BioCheck Beta-2 Microglobulin EIA Test KitBC-1061BC-10612019-10-08
00850392007152BioCheck Testosterone EIA Test KitBC-1115BC-11152019-07-30

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10673486014020Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Dipstick TestTECO DIAGNOSTICSJHI2026-04-09
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80810164510101Atida hCG Pregnancy Rapid Combo TestACESO LABORATORIES INC.JHI2026-03-23
10673486014006Teco Diagnostics One-Step Pregnancy Dipstick TestTECO DIAGNOSTICSJHI2026-02-12
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